1. Representing and registration of manufacturer and medical device
2. Guidance in creating technical documentation
3.Reviewing and identifying gaps in your technical documentation
4.Consultation in incident reporting
5.Safeguarding and ensuring compliance with regulatory updates
1. Manufacturer registration
2. Devices Registration of 510 K exempt Products
3.Devices Registration of 510 K Products
4.Guidance in preparation of technical documentation
5.FDA audit compliance services
1. Representing and registration of manufacturer and medical device
2. Guidance in creating technical documentation
3.Reviewing and identifying gaps in your technical documentation
4.Consultation in incident reporting
5.Safeguarding and ensuring compliance with regulatory updates
We are a leading Total Quality Assurance provider specializing in the field of medical devices industry worldwide. We are one stop solution for inspections, trainings, CE marking, ISO certifications & testing of electrical & electromedical products. We provide customized solutions to help you achieve and effectively maintain your regulatory and commercial success.
Our Services
EU Authorised Representative
We monitor vigilance issues related to your product and are the contact person on your behalf for European Authorities
