Regulatory Affairs

Alceon can help you in the following areas of Regulatory Affairs:

• Technical File Construction for various regulations including EU MDR, US FDA (510K, De Novo, PMA) and others
• Clinical Evaluation Report preparation
• Risk Management File creation
• Usability Test Plans and Reports; we can also help conduct usability testing through strategic collaborations with usability research and testing labs
• Conduct Biological Risk Assessments, Design Biological Evaluation Plans, and Write Biological Evaluation Reports
• Conduct Gap Analysis of your existing documents

Our team consists of experienced professionals who have worked in medical device companies spanning multiple devices such as cardiac, orthopedic, wound care and general clinical use. The team is overseen by an experienced medical device professional and our documents are independently reviewed by senior external consultants who have worked for regulatory agencies and medical device companies

 

We don't stop at just writing your documents! Our team is available to provide personalized support throughout your application process, to guide you in areas such as classification, validation, testing and to respond to queries from the regulatory agencies.