BSDpharma has focused its service activities on medical device development.
From our long experience we are able to offer topclass quality medical device development services to the European market.
We offer you,
- Expertise in all areas of Medical Device Development - ranging from proof of concept to manufacturing
- Expertise in various areas including Gynaecology, Urology, Orthopaedics, Wound Healing, Proctology, Cosmetic Surgery
Our R&D Services cover,
- Concept Generation
- Product Development
- Pilot Manufacturing
- Product & Process Verification
- Clinical Trials
- Clinical Evaluation
- CE marking requirements
- Medical devices regulatory affairs
Medical device clinical trial service is one of our key features.
BSDpharma is able to provide a full-service clinical trial development for your medical device.
All clinical studies will be performed according to:
- MEDDEV 2.7.1 current revision
- ISO 14155-1
- ISO 14155-2
Contact us to learn more about our clinical trial services
MEDICAL DEVICES REGULATORY AFFAIRS
Our consultants have the expertise to help your medical device meet
the many challenges of medical device regulations during the approval process,
for products in Europe.
Our services include:
- Implement or review your existing CE Marking Technical File.
- Verification of Essential Requirements.
- Choose the most appropriate Conformity Assessment Route.
- Product classification and identification of applicable standards for medical devices.
- Implementation and maintenance of your ISO 13485 quality systems if needed.
- Product labeling and packaging review.
- Risk assessment and management (ISO 14971).
- Development of Vigilance and Post Market Surveillance activities on your behalf.
- Serving as your European Authorized Representative.
Contact us to learn more about our medical device regulatory activity services
Serving as your European Authorized Representative
If you have no physical location in Europe the Authorized Representative registers your devices with the national Competent Authorities before they are marketed.
- Acts as your primary contact point for all national Competent Authorities.
- Maintains an updated copy of your Technical File available for inspection by the European Competent Authorities.
- Interacts between you and the National Competent Authority, when necessary.
- Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
- Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
- Maintains reports concerning the critical evaluation of all data collected during Post Marketing Surveillance and Vigilance for review by Competent Authorities.
- Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.