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.