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The range of products which fall under the medical devices umbrella is vast. They are divided into distinct classifications from devices covered by the Medical Devices Directive (in the EU) to active implantable medical devices and in vitro diagnostic medical devices. The purpose of the legislation is to ensure that devices achieve a mandatory safety standard. It is therefore important that the regulations for each region and/or country are clearly understood in order to apply them appropriately.
How can we help?
Our experienced consultants can provide advice from initial product development, through to the designing of studies and the acquisition of appropriate approvals. We can provide detailed technical evaluation of all documentation against relevant requirements; providing advice on regulatory, scientific and quality aspects, as well as other relevant standards. In addition we can review your existing device vigilance procedures, providing advice on appropriateness with respect to compliance and guidance, as well as helping to determine which legislation a product falls within where its classification is on the borderline.
Our certificated staff can also complete quality audits of companies, their suppliers and subcontractors or help establish quality systems compliant with international standards including ISO 9001 and ISO 13485.
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. Our experience with the registration of such products with both drug and device regulatory authorities, is extensive.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION