How MDX Supports Medical Device Manufacturers | MDR & IVDR Regulatory Strategy
Автор: MDx CRO
Загружено: 2026-02-12
Просмотров: 4
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How can medical device manufacturers successfully navigate MDR and IVDR requirements?
In this interview, Victoria explains how MDx supports companies across the entire product lifecycle, from early-stage development to market launch and post-market compliance.
With a comprehensive portfolio of regulatory and quality services, MDXx partners with manufacturers to develop strong regulatory strategies, prepare technical documentation, and ensure alignment with evolving European regulations.
Under MDR and IVDR, regulatory writing has become significantly more complex compared to previous Directives. One of the biggest challenges is the requirement for robust clinical evaluation, including the systematic gathering, analysis and critical appraisal of high-quality clinical data to demonstrate safety and performance.
MDx supports manufacturers with:
• MDR and IVDR regulatory strategy
• Clinical Evaluation Reports (CER) and Performance Evaluation documentation
• Technical documentation preparation
• Quality and regulatory documentation
• Ongoing compliance with evolving regulatory requirements
Our services are designed to meet the needs of the full medical device and IVD industry spectrum, from innovative start-ups to established global manufacturers.
Watch the full interview to learn how MDX helps companies grow while staying compliant in an increasingly demanding regulatory environment.
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