Our Medical Device Services
REGULATORY CONSULTANCY
Kinesys Consulting works with you to navigate the complexities of medical device regulations, from classification queries to full regulatory submissions.
DRUG-DEVICE COMBINATIONS (DDC)
Kinesys Consulting has expertise in both the medical device and medicinal product regulations under one roof. We coordinate our internal resources to offer the best outcome in relation to DDC compliance.
CE MARKING
There are many routes open to achieving a CE mark for a medical device. Factors that influence the route include the classification of the device, the costs involved in clinical investigation or clinical evaluation and the intended use of the device.
UKCA MARKING
Following Brexit, medical devices in Great Britain are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
UK RESPONSIBLE PERSON SERVICE
The UK left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices. Kinesys offers a UK Responsible Person service that allows us to register your products with the MHRA (MHRA Account no. 022797).
INTERNAL AND SUPPLIER AUDITS
Medical device manufacturers can often be challenged in relation to auditor independence and resource requirements when fulfilling their internal audit program.