Medical Device Services
We offer a full range of consultancy services relating to medical devices and in vitro diagnostics.
Wainwright Associates Limited offers wide-ranging consultancy services relating to medical devices, in vitro diagnostics, as well as medicinal products. 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; including design of suitable studies to meet regulatory requirements and achieving timely access to market in countries of interest. Audits of client companies, their suppliers and subcontractors can be undertaken by our specialist auditors to ensure that the appropriate standards of quality are met.
In the European Union, harmonised rules relating to regulation of medical devices are defined by three Directives:
- Medical Devices (93/42/EEC);
- Active Implantable Medical Devices (90/385/EEC); and
- In Vitro Diagnostic Medical Devices (98/79/EC).
Furthermore, a variety of non-legally binding guidance documents (e.g. MEDDEV), assist with ensuring uniform application of relevant provisions of these Directives within the EU.
In principle, products bearing a 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. We can provide advice on the optimum route to market and assistance with classification, essential requirement checklists, risk analysis, compilation of technical documentation or design dossiers, and other preparations for conformity assessment, as appropriate. Where applicable, we can provide a recommendation as to which Notified Body may best suit the situation and, if required, acting as the point of liaison.
We handle all types of products: active and non-active devices, including sterile and electromedical products, in vitro diagnostics, as well as drug-device combinations and borderline products. Our multidisciplinary team can provide detailed technical evaluation of all documentation against relevant requirements; providing advice on regulatory, scientific and quality aspects, including ISO 13485 and other relevant standards.
EU guidance on a Medical Devices Vigilance System (currently, MEDDEV 2.12‑1 Rev 8; January 2013) facilitates uniform application of requirements.
Wainwright Associates can review your existing vigilance procedures and advise on appropriateness with respect to compliance with relevant guidance. Alternatively, we can assist with setup and operation of an appropriate vigilance system, including implementation of medical device vigilance procedures. This may range from advice as to what procedures are required to preparation of written procedures. Documents can be prepared either in our own house style or according to a client’s template, as required.
In addition, if required, we can undertake to carry out day-to-day device vigilance activities on your behalf. 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; and/or
- follow-up with the Competent Authorities as required.
The Drug-Device Borderline
Regulatory requirements for borderline products vary enormously from jurisdiction to jurisdiction and it is not always easy to determine whether a product falls within drug or device legislation, or is perhaps regulated by other means. Thus, specialist knowledge will be invaluable in developing a global marketing strategy.
Wainwright Associates are experienced with both sides of the drug-device borderline and can, therefore, help to clarify specific regulatory issues that would apply in a particular case, as well as working towards successful achievement of marketed status in territories of interest.
Our international network of local advisors, in over 70 countries, allows us to determine both the regulatory requirements and likely attitudes of regulators around the world toward novel and unusual types of medical device.
In the case of drug-device combinations, we have assisted many clients in the development of their products; planning studies required for multinational launches and establishing satisfactory quality systems. We have considerable experience of the regulation of such products by drug and device regulatory authorities alike.