Category: Patrick Gora

Predictive maintenance is a game-changing strategy to ensure medical device reliability while maintaining compliance with stringent regulatory standards.

We explore the common areas of focus during an EU MDR audit and provide actionable steps to ensure your organization is well-prepared.

We explore the similarities and differences between FDA and EU regulatory submission pathways and discuss strategies for harmonizing compliance efforts across these regions.

We delve into the EU MDR, its key provisions, the timeline for implementation, and the challenges and opportunities it presents for the medical device industry.

We explore the quality assurance practices in medical device manufacturing, focusing on process validation, risk management, and continuous improvement.

We explore the hurdles encountered by medical device manufacturers and practical solutions to facilitate compliance.