OPTIM Associates, Inc

OPTIM Associates, Inc. | UT & WI | (847) 707-7560

Auditing

Baseline Audits

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Baseline Audits establish the “base-line” regulatory compliance health evaluation of the Quality System and documents any associated Quality System gaps.


These audits may be performed for many reasons including periodic health exam, as part of due diligence company purchase or as a result of FDA enforcement action: 483, Warning Letter or Consent Decree.


Regardless of the reason, OPTIM Associates ensures an independent and thorough examination of your Quality System. 

 

For information how OPTIM Associates can help with Base Line Audits, contact us at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Verification Audits

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Verification Audits confirm progress against Baseline Audit findings or are used to periodically review and confirm progress against FDA enforcement actions: 483, Warning Letter or Consent Decree.


While the overall scope of verification audits are system-level, execution of verification audits may be phased to your unique regulatory compliance needs.


Regardless of the reason, OPTIM Associates ensures an independent and thorough verification audits with an execution plan geared to the Baseline Audit results or as part of Remediation activities.

 

For information how OPTIM Associates can help with Verification Audits, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Internal Audits & Assessments

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We understand that your internal audit plan may be extensive (i.e., Global) with aggressive schedules. 


OPTIM Associates can augment audit schedules with expert resources to maintain schedules and provide independent experts to maintain compliance.


As a companion to Internal Audits, a less formal Internal Assessment may be helpful to quickly provide feedback to management without the structure of an Internal Audit.


Regardless of your needs, OPTIM Associates ensures qualified professional expertise within your Internal Audit program or performance of Internal Assessments. 

 

For information how OPTIM Associates can help with Internal Audits and Assessments, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Pre-Approval Audits & Mock Inspections

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Preparing the entire organization for an impending FDA Inspection is critical for success. Using the “hats-on / hats-off” technique OPTIM Associates will coach and mentor all those who will interface with the FDA. This includes, but is not limited to expected topics, expected threads, how to listen, act, react and answer questions, what to truthfully say and not say, and how to respond.


OPTIM Associates can also provide valuable assessment and plans for expected inspection logistics.  Items include Receiving Investigators, Daily Schedules, Front Room(s), Back Rooms(s), Scribes and internal SME roles and responsibilities to name a few.


OPTIM Associates can help with an expected Pre-approval Audit as a result of new product development. These audits are specific product focused with special emphasis on elements of the Design History File (DHF), D-Verification, D-Validation, Risk Management, DMR and Process Validations.


Regardless of your anticipated inspection needs, OPTIM Associates ensures qualified professional expertise to make your agency inspections are as efficient and effective as possible. 

 

For information how OPTIM Associates can help with Pre-Approval Audits and Inspection Readinesss, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Supplier Audits

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Supplier Controls are a focus of the FDA and are in the top 5 list of findings. Often times Supplier Audits don’t receive adequate attention due to lack of resources, expertise or oversight.


Since the finished device manufacturer is responsible for their suppliers—contract manufacturers and components manufacturers alike—OPTIM Associates can bring to bear adequate resources and expertise to make sure your suppliers don’t jeopardize your compliance status.


Regardless of your needs, OPTIM Associates ensures qualified professional expertise to optimize your Supplier Audit Plan or augment your existing plan.

 

For information how OPTIM Associates can help with your Supplier Audit Program, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Quality System & Process Audits

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OPTIM Associates performs audits of your entire Quality System using the FDA Guide to Inspections of Quality Systems (QSIT), August 1999. Additionally, we are building the capability to conduct Medical Device Single Audit Program (MDSAP) preparatoryaudits.


If an audit of your entire Quality System is not necessary or warranted, OPTIM Associates also performs targeted “sub-system” Process Audits of individual quality system elements: CAPA, Design Controls, Risk Management, and Production & Process Controls to name a few.


Because your Quality System needs to remain compliant and efficient, OPTIM Associates ensures qualified professional expertise to actively evaluate and optimize your overall Quality System or individual Processes.

 

For information how OPTIM Associates can help with QS & Process Audits, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Quality Systems Development & OPTIMIZation

Quality Systems Development

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Your Quality System (QS) is the fundamental entry requirement for medical device success. As such your QS needs to be treated as an investment and not a cost-center. Your QS needs to be scalable to your current business demands and continually grow along-side your evolving business processes.


The costs of poorly developed QS can be significant--increased FDA Scrutiny, QS Remediation, Financial Penalties and Brand Integrity. The resulting increased legal, operating costs and loss of market entry or market share reacting to Quality Deficiencies, Corrections & Removals and Lawsuits definitely outweigh the proactive vigilant maintenance and Optimization of Quality Systems.


OPTIM Associates develops compliant, scalable and sustainable Quality Systems for all company sizes regardless of your business life-cycle or global market needs. Our solutions integrate Regulations, Guidances, International Standards, Global Harmonized Task Force Recommendations, and proven industry Best Practices.

 

For information how OPTIM Associates can help Develop your Quality System, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Quality System Optimization

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 Your existing Quality System (QS) is a dynamic element of your on-going business success. As your business grows and changes, so must your QS. Additional employees, additional organizational functions, additional products, additional site locations and business acquisitions all contribute to QS Optimization.


Similar to a health and wellness check-up, an Optimization Assessment identifies areas for procedure / process improvements, organizational effectiveness and maintaining your QS investment including skills, roles, responsibilities, technology, global harmonized standards, regulatory requirements and procedures.


OPTIM Associates expertise ensures the three pillars of your business—Regulatory Compliance, Organizational Effectiveness and Financial Results—remain in synch and mutually supportive of your strategic goals.

 

For information how OPTIM Associates can help OPTIMIZE your Quality System, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Mergers & Acquisitions

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 Business mergers and acquisitions are well-known and common place in the medical device market. They grow market share and profits. Often times harmonization of two or more different Quality Systems is given less emphasis thereby creating operational inefficiencies and increasing regulatory compliance risks.


OPTIM Associates has a proven track record of integrating and harmonizing Quality Systems from acquired / merged companies. Effective integration accomplishes many objectives:

· Ensures continued compliance,

· Ensures shareholder returns (ROI),

· Reduces regulatory compliance risks,

· Reduces financial uncertainty associated with FDA enforcement actions,

· Adds significant and tangible value to the new company bottom line efficiencies.


Because your combined Quality Systems needs to remain compliant and efficient, OPTIM Associates ensures qualified professional expertise to pro-actively evaluate and harmonize multiple Quality Systems or individual Processes.

 

For information how OPTIM Associates can help ensure your Merger & Acquisition is seamless, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Remediation: Quality Systems & Products

Quality Systems Remediation

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QS Remediation Defined:

Quality Systems Remediation is the process of recognizing change is necessary, identifying systemic issues, performing Root Cause Analysis, creating a plan—or plans—for immediate correction and future prevention of the resurfacing of the issues and then execute to the plan(s). 


This often requires outside assistance of a proven capable partner that understands the dynamics of what it takes to quickly and effectively diagnose, plan and resolve QMS / Compliance issues as well as communicating all actions to the FDA.


Proven “Tailored” 6-Step Remediation Process

We work closely with all levels of your organization to develop an “End-to-End Plan” to fit your compliance / business / organizational needs and guide you through the entire process—from developing plan(s), uncovering issues, discovering true root cause(s), developing sustainable solutions, systematically implement corrections and corrective actions—to ensure compliance, organizational and business success.

1. Comprehensive Corrective Action Plan (CAP)

2. System-Wide GAP / Issues Analysis / Root Cause Analysis

3. Solutions Development—Procedures, Infrastructure, Organizational

4. Implementation, Tracking, Training

5. Periodic Assessments / Audits

6. Closure Preparation


OPTIM Associates bring the full force of our expertise to address your compliance, organizational and business challenges to rebuild your company better than it was before. Our team of former FDA and industry professionals have broad and deep understanding of organizational behaviors, FDA regulations and expectations and provides expertise in clearly and regularly communicating with the FDA to meet their expectations.

 

For information how OPTIM Associates can Remediate your Quality System, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Product Remediation

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Product Remediation Defined

While QS Remediation is about re-designing procedures and processes, many times the objective evidence proving fielded products are safe and effective is less than inadequate. OPTIM Associates has a long history helping focus efforts and resources on the essential evidence required to back-fill the necessary design and manufacturing evidence.


OPTIM Associates Value

OPTIM Associates recognizes that during any FDA Enforcement Activity, one of the challenges is to remediate the fielded products that continue the revenue stream while meeting baseline and heightened regulatory scrutiny. OPTIM Associates recognizes what key elements of product characterization are most important for re-establishing safety and effectiveness.


Design Objective Evidence

· Identification of Essential Design Outputs (EDO’s)

· Design Input Requirements and Specifications associated with EDO’s.

· Design Verification and Validation associated with EDO’s.

· Risk Management File, Hazards Analysis and Design Risk Controls evidence associated with EDO’s.


Manufacturing Objective Evidence

· Identification of Essential Manufacturing Requirements and Specifications.

· Re-establish Production Processes

· Modify Manufacturing Work Instructions

· Manufacturing Risk Controls, including In-coming, In-Process, Final Inspections.

· Targeted P-FMEA Development, including Process Maps, Mfg. Controls, VOI and VOE.

· Verification of Risk Control Effectiveness, including Process Validations and Test Method Validations


OPTIM Associates bring the full force of our expertise to address your compliance, organizational and business challenges to rebuild your company better than it was before. Our team of former FDA and industry professionals have broad and deep understanding of organizational behaviors, FDA regulations and expectations and the essential elements of product remediation to quickly prove your products are still safe and effective.

 

For information how OPTIM Associates can Remediate your products, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

OPTIM Associates Value

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OPTIM Associates recognizes that “time is money” and companies needing QS Remediation—483, Warning Letters, Consent Decrees, Import Detentions—did not get there overnight…rather many years of sub-optimal decisions throughout the company at all levels. Identifying and modifying key decisions along with changing organizational behaviors to meet regulatory compliance expectations is crucial to quick and effective QS Remediation.


Additionally, our value is enhanced by providing the full range of high value experts needed to plan and implement the program. Not only will our team get the job done, the consequences—risks, conflicts, rework, increased costs—are greatly minimized instead of having multiple consulting groups vie for strategic and tactical influence. High Value Experts include,

· Senior Executive Advisor

· Technical Project Lead

· Non-Technical Program Manager

· QS Topical Subject Matter Experts (SME’s)

· Auditors / Trainers / Project Managers (as necessary)

· Interim Staffing / Resource Augmentation (as necessary)


OPTIM Associates bring the full force of our expertise to address your compliance, organizational and business challenges to rebuild your company better than it was before. Our team of former FDA and industry professionals have broad and deep understanding of organizational behaviors, FDA regulations and expectations and provides expertise in clearly and regularly communicating with the FDA to meet their expectations.

 

For information how OPTIM Associates can add significant Value to your bottom line, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Medical Device Start Ups

510(k) & PMA

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OPTIM Associates understands what it takes to get a device approved by FDA and/or EU and bring your product to market. We completely understand how many milestones and deliverables need to be accomplished sometimes with limited funding / financing.


· Proof of Concept

· Supplier Selection & Qualification

· Prototyping,

· Scalable QS Development, including Design Controls, Risk Management, Mfg. Processes

· Third-Party Manufacturing

· Regulatory Approvals: 510(k), PMA, EU Approval

· Pre-Approval Audits: DHF, DMR, D-Ver, D-Val, Risk Management, P&PC

· Much more


OPTIM Associates provides you with qualified professional expertise to help you each step of the way—from 510(k) application to developing scalable and compliant QMS that can grow as your business grows.

 

For information how OPTIM Associates can get your product to market and set up a Scalable Quality System, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Training

Overview

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Often times, personnel are not trained to adequately perform their assigned responsibilities or are not made aware of device defects which may occur from the improper performance of their specific jobs.


OPTIM Associates recognizes and uses proven Universal Instructional Design (UID) Principles when developing and delivering our training experiences. There are multiple learning styles—visual, “hands-on”, lecture, individual work, group work, creative thinking, linear thinking.


Our consultants listen and take the time necessary to understand your products, people, and processes before developing a curriculum and effective training materials. While we have pre-developed materials, they are not a “one-size-fits-all”. We customize materials to the specific needs of your organization.


OPTIM Associates ensures qualified professional expertise to effectively develop and deliver training materials and create effectiveness measuring criteria.

 

For information how OPTIM Associates can help with your Training Program, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Training Topics

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We provide training for a wide variety of topics, including but not limited to the following:


· FDA Inspection Preparedness.


· FDA Regulations: 21CFR820, 21CFR803, and 21CFR806.


· OUS Regulations: EU-MDR and more.


· Auditing: QSR, QSIT, MDSAP, Internal, Supplier


· Best Practices: CAPA, Root Cause, Reliability and Risk Management.


· International Standards: ISO13485, IEC60601, ISO14971, IEC62366, IEC62304.

 

 

For information how OPTIM Associates can help with your Training Program, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Learning Domains

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Our delivery and materials address the Key Universal Instructional Design (UID) Learning Domains:
 

· Concepts


· Decision Making (at all levels)


· Engineering


· Management (at all levels)


· Problem Solving


· Procedures


· Reasoning


Verification of Training Effectiveness

OPTIM Associates ensures qualified professional expertise to effectively develop and deliver training materials. Then once the training has been delivered, how do you measure effectiveness? OPTIM Associates has been trained by educational testing organizations to develop effective, fair and reliable Selected-Response (i.e., Multiple Choice) exams to accurately establish Verification of Training Effectiveness (VOE).

 

For information how OPTIM Associates can help with your Training Program, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Expert Witness

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During the life-cycle of your products, you may have needs for a device expert witness to attest to Safety and Efficacy. OPTIM Associates has qualified professionals trained in regulations with skills navigating the legal process.


If you need an expert witness, demonstrating Safety and Efficacy should not be left to chance. These cases require qualified experts to objectively and clearly “connect the dots” back to how the regulatory requirements were met.

 

For information how OPTIM Associates can attest to Safety and Efficacy, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Tobacco & E-Cigarettes

Retail, Combustables, ENDS

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The E-Cigarette market is exploding and FDA is extremely concerned about the “epidemic” of underage use. OPTIM Associates understands the issues—Deeming Regulation, Sales Restrictions, Warnings, Flavors and Pre-Market Tobacco Product Applications (PMTA).


While the specific ENDS (Electronic Nicotine Delivery Systems) regulations are not yet published, the PMTA deadline is looming. The FDA has signaled that using the 820 Model for Medical Devices is a solid approach. If you want to market your ENDS product for tobacco cessation or for any other therapeutic purpose, FDA has also indicated that the product will be regulated as a drug or device.


OPTIM Associates has extensive experience meeting existing Retail Sales Restrictions, Warning Labeling and developing scalable and effective QS for ENDS companies that can be easily optimized as the specific regulations are developed.

 

For information how OPTIM Associates can help navigate developing ENDS Regulations, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Interim Staffing & Resourcing

On-Going Needs

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OPTIM Associates recognizes the challenges of evolving and managing your Quality System regardless of regulatory scrutiny. Regardless of your need—Healthy Operations or Remediation Efforts—resource management is a required element of ensuring that Quality Management Systems are effectively performing to regulatory and business expectations.


OPTIM Associates is uniquely positioned and qualified to assist in providing experienced professionals to fill unexpected vacancies or immediate remediation demands. Our quality system professionals draw on years of experience and specialized expertise / skills to ensure compliance and achievement of on-going business objectives.

 

For information how OPTIM Associates can enhance your Human Resource needs, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

How We Can Help

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OPTIM Associates provides the full range of expertise from Strategic Leadership to Tactical Execution.


· Executive Guidance and Policy Preparation.


· Quality Procedures Development.


· Planning, executing and/or managing remediation projects.


· CAPA Coaching and Root Cause Investigations.


· Performing Multiple Audits, including Internal & Supplier Audits.


· Performing MDSAP Audits.


· Planning and executing mock FDA inspections.


· Provide Contract employment for variable needs.


· Back-fill employment vacancies.


· Quality Coaching / Mentoring at technical level.

 

For information how OPTIM Associates can enhance your Human Resource needs, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Benefits of OPTIM Associates

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Interim VP, Directors and Managers—OPTIM Associates provides you with interim Executives and Leaders capable of managing and mentoring essential departments: Quality, Quality Systems, Risk Management, Research & Development, Regulatory Affairs, Operations, Manufacturing, and Supply Chain/Sourcing.

  

Project Consultants—OPTIM Associates provides you with experienced project-oriented consultants to support your team and execute activities / tasks: Quality, Quality Systems, Risk Management, Research & Development, Regulatory Affairs, Operations, Manufacturing, and Supply Chain/Sourcing.


Interim Contract Employees—OPTIM Associates provides you with temporary professional employees capable of performing the activities and tasks within all areas of your Quality System: Quality Engineering, Quality Technicians, Validation, Testing, Metrology, Calibration to name only a few.

 

For information how OPTIM Associates can enhance your Human Resource needs, contact us  

at information@optimassociates.com

(847) 707-7560

(262) 348-8404

Specific Programs

Risk Management

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Importance of Risk Management

Your risk management process is an integral element of your Quality Management System. Whether you are seeking to (re) design a Risk Management process or (re) design a new medical device product your risk management process must be robust, effective and efficient.


A poorly designed Risk Management program not only affects your design development process, budget and timelines, but also impacts your on-going organizational efficiencies and effectiveness when evaluating CAPA’s, Complaints and Non-Conformances.

Risk Management is fundamental to daily QMS operations as well as FDA & CE product approval process.


OPTIM-ized Risk Management Process

A compliant Risk Management process comes in many forms. The key is to tailor your Risk Management program to align with your company needs including company size, budgets, and organizational maturity.


Finding the proper balance for your company, your Quality Management System and associated Medical Devices is what OPTIM Associates excels.


Our expertise and experience developing and implementing Risk Management programs for companies – pro-active and regulatory enforcement actions – reduces and/or eliminates regulatory exposure while increasing bottom line returns and organizational efficiencies.


OPTIM Associates expertise doesn’t end with Risk Management program development. Our extensive experience with Risk Management extends to program implementation including Training, Coaching, Mentoring and Risk Management File (RMF) Remediation efforts.


EN ISO 14971-2012 Medical devices — Application of risk management to medical devices

This is the FDA recognized consensus standard establishing, documenting and maintaining the ongoing process throughout the product life cycle for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.


Reliance on traditional outdated FMEA techniques are not sufficient to meet the requirements of 14971, can hinder your implementation and place your company at regulatory risk.


Even though it has been in effect since 2012, the content deviations spelled out in Annex ZA, ZB, and ZC still provide implementation and regulatory challenges, especially if not fully understood.


OPTIM Associates has deep expertise and extensive experience blending the best elements of Risk Analysis tools—Design FMEA, Usability FMEA, Process FMEA—and integrates them with the System-Level Hazard Analysis process to create an efficient and effective process that is not only compliant but sustainable with the least amount of resources and time.

Usability / Human Factors Engineering

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Usability and Human Factors Engineering assesses and mitigates Risks caused by Usability problems associated with Correct Use and Use Errors (i.e., Normal Use) as it relates to Safety of a Medical Device for the patient, user and others.


As stated in IEC 62366, Medical devices - Application of usability engineering to medical devices, Risk Management is “indispensable” for understanding and implementing the Usability Engineering process.


OPTIM Associates has deep expertise and extensive experience developing and implementing Usability Engineering programs tightly integrated with Risk Management that reduces and/or eliminates regulatory exposure while increasing bottom line returns and organizational efficiencies.


OPTIM Associates expertise doesn’t end with Usability Engineering program development. Our extensive experience with Usability Engineering extends to program implementation including Training, Coaching, Mentoring and Usability Engineering File (UEF) Remediation efforts.

Software Development Life Cycle

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Software Hazard Analysis is a process which applies to the development and maintenance of Medical Device Software when the software is itself a Medical Device or when software is an embedded or integral part of the final Medical Device.


As stated in IEC 62304, Medical Device Software – Software Life Cycle Processes, Risk Management provides a management environment that lays a foundation for an organization to develop safe and effective products.


OPTIM Associates has deep expertise and extensive experience developing and implementing SDLC programs tightly integrated with Risk Management that reduces and/or eliminates regulatory exposure while increasing bottom line returns and organizational efficiencies.


OPTIM Associates expertise doesn’t end with SDLC program development. Our extensive experience with SDLC extends to program implementation including Training, Coaching, Mentoring and Software Remediation efforts.