November 2016 Posts

CGMP and ISO 13485: Aligning Device Quality Worldwide

CGMP and ISO 13485: Aligning Device Quality Worldwide

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Regulators around the world commonly assess product design to ensure safety and efficacy in medical devices. The product approval process is key to ensuring the safety and efficacy of life-improving and life-saving products introduced into their market. However, oversight does not stop there. Worldwide, regulatory bodies are looking to ensure sustainability; they need to “see” that an organization can continuously produce and provide safe, quality product to their market. How do they do that? By auditing an organization’s quality system.
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Key Takeaways from This Week’s ISO 13485:2016 Knowledge Exchange

Key Takeaways from This Week’s ISO 13485:2016 Knowledge Exchange

Deb Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions

Earlier this week, we hosted a webinar titled “ISO 13485:2016 – Will Your Transition Be a Marathon or a Sprint?” This webinar is the first in a series of four webinars that Pilgrim will be hosting to support medical device organizations during the transition to ISO 13485:2016.

In the webinar, Dan O’Leary, President of OMBU Enterprises, presented an overview of changes to the standard, as well as a deeper dive into the areas of Risk, Design Control, Supplier Management, and CAPA. The presentation provided additional insights that went beyond the standard to help everyone who attended get a handle on the scope of their transition.
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