Commercialization
Regulatory Strategy Services
Reimbursement Services
Medical Device Due Diligence
Medical Device Market Analysis
Medical Device Services
Quality Management
Quality Management Systems: ISO 13485
Quality manager
Person Responsible for Regulatory Compliance (PRRC)
Auditing for Quality Management Systems and Technical Files
Technical File
Medical Device Technical Files for EU CE Marking
Clinical Evaluation Reports (CER) under the EU MDR
Biological Evaluation Reports (BER) under the EU MDR
FDA Approval
Consulting
Quality Assurance and Regulatory Compliance Consulting
European Authorized Representative
Medical Device Testing: ISO 10993
Medical Device Testing: IEC 60601
Medical Device and Quality Management Training
CRO
CRO Project Management Services
CRA and Monitoring
Auditing Services and Quality Management for Clinical Trials
Good Laboratory Practice (GLP) Studies
Blog
Contact details
Careers at MDS
Book a meeting