Compliance services

Compliance route determination and CE marking/510(k) strategy, together with the realisation of the necessary technical, risk analysis and validation documentation  

Omsbar provides compliance route determination and CE marking strategy according to the following directives:

      • Medical Device Directive
      • In-vitro Diagnostics Directive
      • Active Implantable Medical Device Directive
      • Compliance with part 2 standards (eg infusion pumps, endoscopes, etc)

Requirements for other countries also apply where regulatory approvals are necessary. Such countries include

  • USA
  • Canada
  • Japan
  • Korea
  • Australia
  • China

The medical device directives and legislation require that a device is classified and the feasible routes to compliance are then determined from its classification. Selecting the correct classification and the subsequent route to compliance is not always obvious and can have a big effect on the work necessary to show compliance. Requirements for compliance are systematically satisfied and presented in the form of a Technical File, Design Dossier, 510(k), etc. Effective manufacturing solutions and routes to market may then be determined.

Omsbar capability

Many technical files/design dossiers and 510(k)s have been created, authored and negotiated successfully with Notified Bodies and the FDA resulting in CE marking and approval to market respectively. These files describe products ranging from sterile single use devices, electromechanical systems and critical software controllers through to implantable devices.

Successful registrations are also applied for and achieved in countries where registration is mandatory.

We also act as an EU Authorised Representative when so required.

As engineers, we also contribute directly to this process in a technical way. We understand not only what sections of a 510k or technical file are required together with applicable standards and we can also extract  information from client documents and prepare technical documentation directly for submission. It is a common mistake to believe that electronics engineers, software engineers, production engineers et al. know all this; very often they don’t and delays and confusion can arise. We are experienced in all this work and provide not only direct input but also help and guidance to the client’s entire engineering and manufacturing teams.

 

Anonymised Medical Device Label Anonymised Medical Device Label
There is an abundance of symbols here. The label is designed to be compatible with North American and EU requirements and is language independent