Compliance services omsbar 3x squares icon

Quality systems and regulatory affairsomsbar 3 squares icon

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

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 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.

Directives require that companies operate a quality management system to ensure that all products released for use conform to essential requirements both in terms of not only the product design and its validation but also its manufacture. In particular, the Directives require that a systematic hazard analysis be undertaken with respect to the device and its manufacture to ensure that benefits to the patient outweigh risks to them when using devices.

ISO13485: 2012 indicates quality management requirements for medical device manufacturers. Quality management principles extend to many areas of the world where design assessment and site registrations are required prior to selling. Such countries include USA, Canada, Australia and Japan. Countries such as Canada have adopted ISO13485 for their own regulatory requirements while others such as the USA remain orientated towards their own quality management system requirements.

Other standards may also apply depending on the client’s product range, client customer needs and nature of manufacturing – for instance:

  • ISO14001 – Environmental Management
  • ISO27001 – Information Security Management
  • IEC62304 – Medical Device Software Lifecycle management

If the client is supplying software to the NHS, specific standards will also apply too.

Other specific standards are also applicable – for instance:

  • ISO14971 – Risk Management Systems
  • IEC62366 – Usability
  • ISO14644 – Design and Management of Clean Rooms
  • ISO14155 – Clinical Investigation
  • IEC80001 – Application of risk management to IT systems containing medical software.

Omsbar capabilityomsbar 3 squares icon

Any organisation wishing to place a medical device on the market for use (not just for sale) MUST comply with legislative requirements. In the EU, this is the Medical Device Directive, in the USA, it is the Code of Federal Regulations, in Canada, it is the Canadian Medical Device Regulations etc.  Note that there are no exceptions to this requirement – compliance is irrespective of company size or turnover. Notified Bodies in particular are now becoming more and more prescriptive in their requirements for certification and this is to the detriment of SME’s and start-ups – you  MUST consider this aspect of getting your product to market.

Omsbar can assist you greatly in this area – we place many devices on the market on behalf of client’s and specify and manage their regulatory affars – this gives us not only insight into the latest requirements being demanded by the regulatory authorities but also how these requirements can be satisfied in the most cost- effective manner.

Omsbar has its own ISO13485 and ISO9001 QMS system to support your enterprise

Omsbar manages the specification, design, authoring and accreditation of quality management systems, standard operating procedures and work instructions for companies who design and manufacture:

  • Small and large volume production quantity  medical devices
  • Complex safety-critical devices and components
  • Products in clean rooms
  • Sterile Products
  • Electro-static sensitive electronics
  • Products which contain or are software in their own right
  • Implantable products which may require product traceability to raw material and component level.

We also ensure that all of the supplemental standards for Risk Management, Usability, Software Control and Clinical Evaluation etc are embedded into the client quality management system. As an engineering company, Omsbar will assess and author these documents if so contacted, in particular, risk analysis and mitigation and usability assessments.

We have Lead Auditing certification – providing auditing and capability assessment services for clients.

Notified Bodies audit Omsbar as its own entity  and also on behalf of clients – as such, we experience many formal audits per year and hence build up a good picture of techniques and trends in the Notified Body auditor field.

We are also experienced in FDA inspection techniques and methods having been on the ‘receiving end’ of several FDA site inspections ourselves and with clients.