Services
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, Dentistry, Wound Healing, Proctology, Aesthetic Surgery
Our R&D Services cover,
- Concept Generation
- Prototyping
- Product Development
- Pilot Manufacturing
- Product & Process Verification
- Clinical Trials
- Clinical Evaluation
- CE marking requirements
- Medical devices regulatory affairs
Clinical trials
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:
- EU MDR 2017/745
- ISO 14155-1
- ISO 14155-2
Contact us to learn more about our clinical trial services (cro@bsdpharma.it).
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 MDR 2017/745.
- 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.
Contact us to learn more about our medical device regulatory activity services (mailbox@bsdpharma.it).