Post for LD

Services that we provide

• CE Certification according to the following.
• MDD (93/42/EEC).
• IVMDD (98/79/EEC).
• EU MDR (2017/745).
• EU IVDR (2017/746).
• USFDA certification process.
• Registration and Medical device listing.
• Premarket Notification/ 510 (k) Submission for Class II Devices.
• Premarket Approval for Class III Devices.
• Indian MDR- Medical Device Rules, 2017.
• Test License and Manufacturing License process.
• Documents preparation according to Checklist.
• ISO 13485:2016- Medical device Quality Management System.
• Medical Device Single Audit Program (MDSAP).
• NIOSH.
• European representative Guidance and support.
• Country registrations.
• Trainings on CE certification, USFDA, Indian MDR, ISO 13485:2016, MDSAP.
• Free Sales Certificates and Test licenses.
• Audit support (IQA, MRM) and Annual Maintenance Contract.
• Document templates sale for Technical Documentation, ISO 13485:2016.