Resources

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding 21 CFR Part 11 and electronic batch records. Q. What is a master...

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations...

Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new...

It is no surprise that over the course of 2021 with the COVID-19 pandemic that businesses have adjusted their model to accommodate FDA audit remote work. Whether that be associates...

Medical Devices When a medical product fails in the field, everyone suffers — not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No...

For medical device manufacturers, technology can be a double-edged sword. The technologies that elevate the quality of life for patients can be used by cybersecurity bad actors to potentially harm...