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By Marcelo Trevino, independent expert | FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence. | |
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By Mark F. Witcher, Ph.D., biopharma operations subject matter expert | Explore how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting medical device risks. | |
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By Sakthivel Thangaiyan | In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance. | |
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| What Is A Bowie-Dick Test And Why Is It Important? | Article | Mesa Laboratories | Effective sterilization is vital in manufacturing. Discover how the Bowie-Dick test ensures vacuum sterilizer performance, safeguards patient safety, and strengthens your sterility assurance program. |
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| Achieving EU GMP Annex 1 Compliance For Contamination Control | Article | By Dr. Ana Kuschel, West Pharmaceutical Services, Inc. | Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products. |
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