OMSBAR provides Clinical evaluation services which are mandatory for any medical device placed on the market in Europe, and is integral to the approval-to-market process in the USA.

Omsbar Medical Device Design Manufacturing and Regulatory Services

Regulatory Affairs
The European Economic Area (EEA) contains the European Economic Community (EEC). EEC law (The European Medical Device Directive) has defined requirements that all medical devices must satisfy. The EEA has adopted these EEC requirements.Other than for simple (Class 1) devices and accessories, every medical device must be assessed for its design and construction principles and techniques by a Notified Body. Devices conforming to these requirements have a mark (the CE marking) applied. Only CE marked devices can be freely sold in the EEA. The United States of America Code of Federal Regulations (CFR) also defines requirements for medical devices to be placed into interstate commerce in the USA. Again, design and construction principles and techniques are assessed prior to first marketing. A common method of satisfying these requirements is to claim ‘substantial equivalence’ with a currently legally marketed medical device. Such a process is colloquially called the ‘510(k)’ process after the section of the CFR invoking the process. Omsbar has in-depth knowledge and experience of such fields including:
	The European Medical Device Directive and CE Marking
	The USA Code of Federal Regulations
	Other European Directives (eg - Low Voltage, EMC, WEEE etc)
	Medical Information and the Data protection Act
	Relevant Standards including electromedical, EMC, sterilisation and biocompatibility
Where a particular skill or expertise is not incorporated in a client’s organisation, Omsbar’s knowledge of the industry can bring together people and organisations with appropriate complementary skills for solving problems efficiently and effectively. We can assess your requirements from an engineering viewpoint and produce your Technical Files and 510k's. We then will guide the application through its regulatory assessment to subsequent approval on your behalf.
For product development, Omsbar principally adheres to the European Medical Device Directive Essential Requirements for CE marking, enabling faster and more cost-effective registration. This requires consideration early on in design cycles of:
	Classification Criteria
	Clinical Evaluation requirements
	Conformity Route
	Applicable Standards
	Essential Requirements compliance
	Hazard Analysis
However, by simultaneously embracing the requirements of the European Medical Device Directive, the FDA and non-USA/non-European regulated markets, it is feasible to develop a global strategy for regulatory compliance that can be both simultaneously and efficiently applied in many markets. For example, nearly all technical elements of a successful 510(k) may be identified within a CE Marking Technical File. By identifying gaps, such as substantial equivalence assessment, and ensuring compliance with acceptable international standards, the work carried out for the Technical File can be transformed into the US 510(k) thereby avoiding uneccessary repetition and hence cost and delay.