Medical Devices In Vitro Diagnostics Combination Products

Practical support to accelerate your market approval.
 
 
Our philosophy is to optimize and customize our advice using a practical approach to support each individual company in the most efficient and cost-effective manner. 
 
 
REGULATORY COMPLIANCE
 
 
Regulations vary depending on the medical device and the market you want to enter. Our specialized teams support you to comply with all necessary regulations.
 
 
CLINICAL EVALUATION
 
 
Verify the clinical safety and performance of your medical device by analyzing clinical data. Assessment can be based on existing literature or a clinical study.
 
 
QUALITY ASSURANCE
 
 
Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.
 
 
How can we help you?
 
GEMAR offers a full regulatory service package for medical device development. Together with our partners, we assist you in chosing the most favourable strategy and taking all necessary steps getting your medical device on the global market.