4 Consequences of Non-Compliance with ISO 13485 Guidelines
Medical device manufacturers should comply with ISO 13485 because it ensures patient safety, enables global market access, reduces regulatory risk. Non-compliance with ISO 13485 can have serious repercussions for medical device manufacturers. This can lead to...
Linking Design Qualification with ISO 14971 Risk Management
In the medical device industry, every design decision must align with safety and regulatory expectations. Design qualification (DQ) validates whether the chosen design, materials, and components meet user needs and regulatory requirements. ISO 14971 provides the...
Effectively Reviewing GMP Documents: A 10-Step Guide
Good manufacturing practice (GMP) documents are the backbone of pharmaceutical quality systems. It serves as controlled records that ensure consistency, traceability, and compliance with regulatory standards. We have prepared a comprehensive guide on how to review GMP...