Medical Device Quality and Certification

We assist clients with laboratory testing, certifications, compliance and regulatory affairs to the extent required by each project. These may include:

• FDA requirements (510k notification, etc)
• GMP/cGMPs (Good Manufacturing Practices)
• Quality Management Systems (QMS), QSRs
• CE Mark, ISO Certification (9000, 9001, 9002, 13485…)
• EMC, EMI, IEC 60601 Compliance
• CSA/UL registration
• IEC 60601 and various FDA Cert’s and registration requirements