• CE Marking
• Product classification
• Preparation of technical files
• Risk assessments
• Quality audits

Wainwright Associates offers wide-ranging consultancy services relating to medical devices and in vitro diagnostics as well as medicinal products. Our team of highly qualified experts includes pharmacists, biologists, chemists and medical practitioners. We can provide advice on product development, preclinical and clinical research, regulatory affairs and quality assurance as well as post-marketing aspects such as vigilance.

Wainwright Associates will be pleased to assist with planning R&D programmes for novel products; designing suitable studies to meet regulatory requirements and achieving timely approvals in the countries of interest. GMP, QSR and ISO 9000 audits of companies, their suppliers and subcontractors can be undertaken by our IRCA certificated lead auditor ensuring that the appropriate standards of quality are met.

CE Marking

Medical device registration in the European Union is now harmonised with four directives in force:

• Medical Devices Directive
• Active Implantable Medical Devices Directive
• In Vitro Diagnostic Medical Devices Directive
• Electromagnetic Compatibility Directive

In principle, products bearing the CE mark can be freely marketed in all member states without further control. Thus the importance of achieving timely CE marking cannot be overemphasised.

First of all we will classify your product to determine which legislation applies and advise on the optimum route to the market. We can assist with technical files, essential requirement documentation, risk assessments, preparations for conformity assessment and, where applicable, recommend which of the many Notified Bodies best suits the situation, acting, if required, as the point of liaison.

Our multidisciplinary team can provide detailed assessment reports of all the technical documentation against the relevant requirements. Thus assembly of all the necessary documentation can be assured to a standard aimed to achieve a successful regulatory approval the first time around.

Our team is available to advise on regulatory, scientific and quality matters, including ISO 9000 and related standards. All types of products are handled, from active and non-active devices, including sterile and electromedical products to in vitro diagnostics as well as drug-device combinations and borderline products.

The Drug-Device Borderline

Regulatory requirements for products falling on the drug-device borderline vary enormously from nation to nation and it is not always easy to determine whether a product falls within drug or device legislation or is unregulated. Thus specialised knowledge is invaluable in reaching a global marketing strategy.

Wainwright Associates are experienced with both sides of the drug-device borderline and can therefore help clarify the specific regulatory issues that would apply in a particular case as well as achieve successful approvals in the territories of interest.

Our international network of local advisors allows us to determine both the regulatory requirements and the likely attitudes of the regulators towards novel and unusual types of medical device in over 50 countries of the world.

In the case of drug-device combinations, we have assisted many clients in the development of their products; planning the studies required for multinational launches and in establishing satisfactory quality systems. We have considerable experience with the registration of such products with both drug and device regulatory authorities.