In the area of Strategic Regulatory Planning, Qserve Consultancy offers the services of senior consultants with many years of experience in top management positions in a variety of medical device disciplines. Drawing on in-house expertise and through our excellent relationships with regulatory authorities and Notified Bodies in both Europe and the US, Qserve Consultancy can guide you to the market faster with the security of knowing that all regulatory and legal requirements have been met. We can help you achieve a better understanding of the Medical Device Directives and related standards, and what will be required for market approval.

Our experts have proven track records in strategy, planning and implementation, and with every phase of product and company development, in areas such as:

• High-risk products
• Combination products
• Borderline Products
• Classification and conformity route assessment
• World-wide regulatory and legal issues
• Product design, development and approval strategies
• Regulatory submissions
• Manufacturing process development and technology assessments
• Outsourcing
• Marketing and distribution 

Qserve’s objective is, through the provision of sound strategic regulatory advice, to guide you in the most efficient and practical way to achieve product registration and market approval.

“We bring you to the market faster”