REGULATORY AFFAIRS
We turn the burden imposed by medical device regulations into a meaningful regulatory strategy delivering bottom line value.
Clariscience supports customers through the entire medical devices regulatory lifecycle, providing a full range of services, including the development of a regulatory strategy based on customers market access plans, the production of all necessary documents and their subsequent submission.
We turn the burden imposed by medical device regulations into a meaningful regulatory strategy delivering bottom line value.
For the medical device industry
CONSULTING
Consulting at the most senior level in support of strategic decisions such as market entry, corporate sales, M&A, IP evaluation, regulatory due diligence.
MDD TO MDR
EU MDR 2017/745 gap assessment and tailored transition strategy for medical device manufacturers and distributors.
REGULATORY MEDICAL WRITING
Preparation of Clinical Evaluation Plans (CEP) and drafting of Clinical Evaluation Reports (CER).
TECHNICAL DOCUMENTATION
Structuring, compiling, reviewing, updating and maintaining technical documentation.
MARKET ACCESS
Developing the optimal regulatory access strategy for European Union, USA, Mexico, India, Saudi Arabia and other selected countries.
NOTIFIED BODY SELECTION
Selecting the Notified Body best fitting your medical device and your organizational culture and structure.
MEDICAL DEVICE CLASSIFICATION
Is your product a medical device? In which risk class does it fall? Assessment, classification and costing implications.
POST-MARKET SURVEILANCE
Supporting the PMS activity and assistance in case of incident involving your device.
DEVICE REGISTRATION
We can help you obtaining approval for your medical device in several countries/markets, working with you to reduce the time-to-market.
REGULATORY HELPDESK
Day-to-day legal and technical helpdesk in support of your internal staff providing fast and reliable answers.
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Service delivered in outsourcing for SMEs on the basis of the provision of the MDR.
TECHNICAL REPRESENTATION
Supporting your staff in dealing with third parties on highly technical and scientific grounds, including key
TESTING PLAN
Support in devising a cost-effective testing strategy from planning phase to execution.
