Medical Device Services

IVD Technical Documentation for the CE Marking

When lodging an application for device conformity assessment with a notified body, the application must include the device's technical documentation. This documentation describes the device's design, manufacture, and performance. While various documents from the device Design History File (DHF) constitute the core of the device's technical documentation, it must also include several IVD-R-specific documents:

CE Marking Certification Assistance

Guidance and support for obtaining CE marking for medical devices.

Clinical Evaluation Report Preparation

Development of clinical evaluation reports for medical devices.

Post-Market Surveillance and Vigilance

Ongoing monitoring and reporting services for device safety.

Commissioning, Qualification, and Validation

Need third-party project or resourcing assistance to support commissioning, qualification, and/or validation activities.

Comprehensive Medical Device Services

Obtain a CDSCO license for medical device manufacturing, as well as import and manufacturing licenses, in India.

Form MD-9

License to Manufacture for Sale or for Distribution of Class C or Class D, which is issued by the central licensing authority.

FDA 510(k) Submission Support

Assistance with FDA 510(k) premarket notification submissions.

Pharmacovigilance

he FDA Group provides life science companies access to highly skilled consultants who can handle a wide range of pharmacovigilance projects and needs. Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle. We help you bring products to market and keep them there

ISO 13485 Quality Management Implementation

Implementation and certification support for ISO 13485 standards.

Form MD-5

License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device, which is issued by state licensing authority.