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Medical Device GMPs

Medical device packaging labeling and distribution worker safety production floor line worker inspecting sterile device box

September 4, 2026

by VelSafe Editorial Team Worker Safety

Medical Device Packaging, Labeling, and Distribution

Medical device filings 510k PMA IDE tips submission checklist and regulatory guides on desk

September 3, 2026

by VelSafe Editorial Team Tips

7 Medical Device Filings Tips: 510(k), PMA, and IDE

Pharmaceutical quality director reviewing FDA warning letter with CAPA dashboard showing open investigations

August 28, 2026

by VelSafe Editorial Team Situational

When Management Fails Quality: An FDA Case Study

Pharmaceutical sterile filling line in a GMP clean room, showing automated bottle filling equipment used in process validation

August 17, 2026

by VelSafe Editorial Team Guides

Process Validation: A Complete Guide for GMP Manufacturers

Medical device quality engineer reviewing ISO 14971 risk management documentation in a device development lab

August 12, 2026

by VelSafe Editorial Team Tips

ISO 14971: 10 Risk Management Tips for Medical Devices

Cleanroom operator reviewing production batch record with QSR and QMSR seven subsystem compliance checklist and February 2026 regulatory update badge

August 10, 2026

by VelSafe Editorial Team Worker Safety

QSR: What Every Medical Device Worker Needs to Know

Quality professional reviewing MDSAP audit documents with five participating regulatory authority cards showing FDA, Health Canada, ANVISA, TGA, and PMDA

August 10, 2026

by VelSafe Editorial Team Tips

Introduction to MDSAP: 10 Things Professionals Must Know

Female pharma technician in lab coat reviewing batch record on cGMP manufacturing line with compliance dashboard overlay

August 9, 2026

by VelSafe Editorial Team Worker Safety

Introduction to cGMPs for Pharmaceutical Workers

Equipment qualification failure GMP case study featured image showing a pharmaceutical worker in cleanroom PPE at a production reactor with a FDA 483 Observations clipboard citing inadequate qualification, missing IQ/OQ/PQ documentation, no process validation evidence, and data integrity concerns, with a Non-Compliance Has Consequences warning barrier.

August 2, 2026

by VelSafe Editorial Team Situational

Equipment Qualification Failure: A GMP Case Study

SITUATIONAL: Equipment Qualification When Equipment Qualification Is Skipped: A Pharmaceutical Facility's Costly Lesson Equipment qualification programmes exist to confirm that manufacturing and laboratory equipment performs as intended withi

High purity water systems practice test featured image showing a pharmaceutical quality engineer reviewing a validation report in front of a stainless steel water purification skid, with a 2x2 stat grid in the bottom bar showing USP conductivity limit, WFI endotoxin limit, hot loop temperature range, and IQ-OQ-PQ validation sequence.

July 30, 2026

by VelSafe Editorial Team Practice Tests

High Purity Water Systems: Practice Test (Pharma)

PRACTICE TEST: High Purity Water Systems High Purity Water Systems: Practice Test and Knowledge Review Test your knowledge of high purity water system types, water quality standards, contamination control, system maintenance, and regulatory req

Medical Device GMPs

Medical Device Packaging, Labeling, and Distribution

7 Medical Device Filings Tips: 510(k), PMA, and IDE

When Management Fails Quality: An FDA Case Study

Process Validation: A Complete Guide for GMP Manufacturers

ISO 14971: 10 Risk Management Tips for Medical Devices

QSR: What Every Medical Device Worker Needs to Know

Introduction to MDSAP: 10 Things Professionals Must Know

Introduction to cGMPs for Pharmaceutical Workers

Equipment Qualification Failure: A GMP Case Study

High Purity Water Systems: Practice Test (Pharma)

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