Setting Strategic Direction for Medical Devices: The Role of Quality Management
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance For companies seeking success in the highly regulated medical device market, setting a strategic direction that emphasizes quality management is a non-negotiable requirement. A well-planned quality management strategy can streamline regulatory compliance, foster innovation, and enhance operational efficiency. Companies that prioritize quality as a […]
Ownership and Accountability in Medical Device Quality Management
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance Accountability and ownership are critical for maintaining high standards of quality in any organization. In the medical device sector, where patient safety is paramount, these elements become even more vital. Effective quality management depends on leaders, teams, and individuals who understand their roles and […]
Embedding Quality Management in Medical Device Business Decisions
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance When it comes to ensuring the safety, effectiveness, and regulatory compliance of medical devices, quality management cannot be left as an afterthought. Business decisions, from the early stages of development to the final stages of manufacturing, must be driven by a commitment to quality. […]
The Crucial Role of Management in Quality for the Medical Device Industry
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the highly regulated medical device industry, quality is not just a checkbox—it is a cornerstone of successful business operations. The importance of quality management in this field cannot be overstated, as it plays a vital role in ensuring product safety, regulatory compliance, and […]
GBA Key2Compliance assists Watson-Marlow Flexicon with QA Manager
“During a critical period for Flexicon, we received invaluable assistance from the consulting firm GBA Key2Compliance, as we were without a Quality Manager for three months. With her expertise, Nadia stepped in and handled everything from customer audits and complaints to inquiries from clients. This enabled us to maintain our high standards and ensure continuity […]
3 keys to a compliant QMS for startups
Effective Quality management can be a challenge, both when you are just getting started and while you are expanding or progressing to a new phase in development. What are the requirements for the QMS? How much is enough? Who can help us with this? Key2Compliance’s Pharma QA team are experts on this. We provide services […]