Service Types

Wainwright Associates Limited offers wide-ranging consultancy services relating to medical devices and in vitro diagnostics. Our team of highly qualified experts includes pharmacists, biologists, microbiologists, 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, ISO 9001 and ISO 13485 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 harmonised with three directives now in force:

• Medical Devices Directive
• Active Implantable Medical Devices Directive
• In Vitro Diagnostic Medical Devices 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.

Wainwright Associates have a wealth of experience with medical devices and in vitro diagnostics, particularly with regard to CE marking. First of all we will classify your product and advise on the optimum route to market. We can assist with technical files, essential requirement documentation, risk analysis, 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 aspects, including ISO 13485 and ISO 9001 and other 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.

Device Vigilance

Wainwright Associates can assist with setup and operation of your medical device vigilance procedures.

As of January 2008 new EU guidelines on the Medical Device Vigilance System came into effect in order to facilitate a uniform application of the requirements described in the EU Medical Device Directives.

Wainwright Associates can review your existing vigilance procedures and advise on appropriateness with respect to compliance with the MEDDEV Guidelines.

Alternatively, we can assist with the development and implementation of an appropriate vigilance system. This may range from advice as to what procedures are required to generation of written procedures themselves to be held as part of your technical file. Documents can be prepared either in our own house style or according to the client's template, as required.

In addition we can undertake to carry out day-to-day device vigilance activities on your behalf if required. This may include:

• documentation and further investigation of any reported incidents;
• assessment and notification to Competent Authorities on your behalf where required;
• generation of Field Safety Corrective Actions where required;
• generation and distribution of Field Safety Notices;

• follow-up with the Competent Authorities as required.

The Drug-Device Borderline

Regulatory requirements for borderline products 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, therefore 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 60 countries of the world, including emerging markets.

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.