Aligning your Compliance Strategy with 1) Overall Business Strategy, 2) Implementation Tactics, and 3) On-Going Organizational Change.
Conducting Remote Audits and Assessments during Covid-19.
There is no question that the current Coronavirus (COVID-19) pandemic and all measures to control it are having a big impact on our personal and business lives. While we are all coping with this disruption, we still need to keep focused on maintaining effective control on our processes and our critical suppliers.
Risk Management for Medical Devices.
As you already know, Risk Management permeates throughout your QMS and is vital for compliance to FDA and EU MDR.
Now that ISO 14971 Risk Management and the companion Technical Report are published, you may be faced with updating your Risk Management Program.
Common Logical Fallacies.
In our professional and personal conversations, not only is clear communication necessary, but it is equally important to be able to recognize questionable statements and arguments.
We have to be constantly vigilant about how we communicate and not fall into the traps of using Logical Fallacies.
Pitfalls when developing and implementing your Risk Management program.
In case you are updating your Risk Management Program we encourage you to be aware of some common Pitfalls.
· The First is Vocabulary and Terminology. ISO14971 has specific terminology that if not rigorously followed and enforced will eventually perpetuate confusion throughout your organization.
· Secondly – Lack of Clinical Responsibilities. Without a strong Clinical presence, harms and severity of harms are determined by unqualified employees.
· Lastly – Linkages to Complaints Program. Without proper links to Complaints, MDR’s and Complaint Probabilities, your RM Program becomes a remote island totally disconnected from customer realities.
What to consider when developing a Process Failure Mode Effects Analysis.
In case you are updating your P-FMEA we encourage you to be aware of eight common Pitfalls.
ISO/IEC 17025-2017, General Requirements for the Competence of Testing and Calibration Laboratories. Specifically, what are the top 3 typical deficiencies found during an audit.
How to effectively meet Quality System Regulation Training Requirements.
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. This is especially critical for employees performing verification and validation activities.
Risk Management Linkages to your key Quality System elements.
As we already know, Risk Management permeates throughout your QMS and both ISO13485 and EU-MDR expect tight integration with RM. When developing or enhancing your RM program, make sure to plan ahead for on-going maintenance and updates to your Risk Management Files.
Measurements and Assessments.
We all know Peter Drucker as the man who coined the phrase “If you can’t measure it, you can’t improve it”. Assessments to regulations and international standards are the first step that establishes a base-line measurement of your processes. Once the unbiased assessment is performed, your organization can now take clear and effective steps to improve both compliance as well as operation efficiency.