Alceon can help you in the following areas of Regulatory Affairs:
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 ex-Notified Body lead assessor 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.