Regulatory Affairs

Ensuring the approval
of your medical device

Regulatory Support

Within the development process of a medical device, STATICE offers its customers, ~~in the form of consulting~~, regulatory support as a service to ensure approvals in different territories, European (CE marking) and international (USA/FDA, China/CFDA, Brasil/ANVISA, …).

For its French customers, STATICE can offer this regulatory support via the BPI system with our approved experts. Services relating to the implementation of QMS and the approval of a medical device may then be eligible for 50% funding from BPI.

Our experts will support you on

Regulatory strategy:

Identification and evaluation of all regulatory options in order to optimize market access (European and international)
Definition of the regulatory class of the device
Recommendations on regulatory approaches and strategic impacts
Identification of actions to be carried out and support in their implementation

Technical file and relations with regulatory authorities:

Usability file according to ISO 62366
Constitution and/or proofreading and/or submission of the technical file
Support in the international registration of your products
Support in the selection of notified bodies
Management of relations with notified bodies or competent authorities

Your Quality Management System (QMS)

Implementation of your QMS in accordance with applicable standards (ISO 13485, 21 CFR Part 820)
Improving your QMS
Setting up your post-market requirements
Assistance in communicating with notified bodies and/or Authorities
Audits

On-site or remote training

Our experts can intervene for tailor-made training on different themes such as:

Regulatory affairs (regulatory strategy, MOR, FDA requirements, technical file, …)
Quality Management System (ISO13485, FDA requirements)
Internal audit
Applicable standards (e.g. ISO 14971, IEC62304, …)