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Regulatory Consultancy

Kinesys Consulting works with you to navigate the complexities of medical device regulations, from classification queries to full regulatory submissions. We have the ability and expertise to develop the necessary technical documentation to demonstrate the conformity of your device to regulatory authorities, auditing organisations and Notified Bodies. 

Kinesys’ experience and expertise in this area is essentially based on high quality people, sound strategy and informed guidance. Kinesys in combining this experience and expertise can help you ensure a successful outcome.

We are strongly positioned to provide guidance and support in relation to drug device combinations, leveraging experience of our staff in both these areas.

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. 

We can help you demonstrate that the general safety and performance requirements relevant to your DDC are met and support you in obtaining CE Marking, a Notified Body Opinion (NBOp) or a Marketing Authorisation. 

Kinesys staff have extensive experience in the preparation and approval of over 100 global Marketing Authorisations. Dossiers have been prepared and submitted globally to EMA, FDA, national European agencies and others such as Health Canada, and TGA.

Based on this wide knowledge we guide and assist you through the pre-application activities, the submission preparation, the review process and the related Agency interactions for your drug-device combination

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.

All products are required to meet the general safety and performance requirements of medical device regulations

Kinesys assists in the development of trials, programmes and activities needed to meet CE Certification requirements as required by the European Medical Device Regulations (2017/745) and IVD Regulations (2017/746)

Services we offer include:

  • Regulatory Roadmaps
  • Technical documentation preparation, including Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
  • Gap analysis of existing regulatory technical documentation
  • Technical writing to fill any gaps in documentation
  • Pre-submission review of the Technical Documentation
  • Corrective action advice for any issues highlighted by a Notified Body

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). 

Kinesys understands that it is vitally important that non-UK based companies retain access to the UK market. We have made the necessary arrangements to align with stated requests from the MHRA.

Compliance requires, from the 30th of June 2023, A UKCA mark and conformity assessment from a UK Approved body for devices that are not CE marked. Non-UK manufacturers are required to appoint a UK Responsible Person who, among other tasks, is required to hold a copy of the full technical documentation for the medical devices placed on the market and to co-operate with the MHRA should the need arise. Kinesys has the necessary skills and expertise to advise organisations to allow them to obtain UKCA marking for their medical devices. 

Services we offer include:

  • Regulatory Roadmaps
  • Technical documentation preparation, including Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
  • Gap analysis of existing regulatory technical documentation
  • Technical writing to fill any gaps in documentation, including from EU to UK requirements
  • Pre-submission review of UKCA Technical Documentation
  • Corrective action advice for any issues highlighted by a UK Approved Body
  • UKRP Services

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).

Kinesys understands that it is vitally important that non-UK based companies retain access to the UK market. We have made the necessary arrangements to align with stated requests from the MHRA.

The UK Medical Devices Regulations 2002 (SI 2002 No 618) (UK MDR 2002) which govern medical devices in the UK, include these extra registration requirements.

We have over 15 years’ experience in the field of regulations regarding medical devices and are at the forefront of regulatory compliance post-Brexit.

Our Service includes:

  • Access to individuals with expert knowledge in regulatory compliance
  • Registration using Kinesys as your responsible person
  • Vigilance tracking and reporting including communication with relevant interested parties
  • Maintaining document files for questions arising from the MHRA
  • General regulatory correspondence in the UK as required

This service conforms fully with the requirements of the MHRA guidance.

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. Kinesys can perform all or part of your internal or supplier audit program to meet the requirements of ISO 13485, using auditors that are familiar with notified body auditing techniques such as ISO 17021 and MDSAP.

  • Develop an Audit Programme from review of previous audit results, areas of risk and to reflect your wider management system
  • Carry out Internal and Supplier Audits with all audit preparation, planning & reporting
  • Verification of audit nonconformities, including analysis of data and trending
  • Provide feedback into the management review meeting via an audit report
  • Audits carried out by IRCA trained and registered Auditors

ISO 13485 Support

All medical device organisations benefit from having an ISO 13485 compliant QMS. It allows organisations to demonstrate to notified bodies that they have the necessary systems in place to routinely meet requirements and regulations associated with their products and manufacturing processes. 

An ISO 13485 certificate from a certification body forms part of the compliance route of most medical device classes. It ensures that the organisation is dedicated to meeting customer and regulatory requirements by adoption of the ‘process approach’, and to improving their system effectiveness by application of the Plan, Do, Check, Act or Deming cycle. 

Implementation of this harmonised standard will ensure that devices comply with the general safety and performance requirements of the medical device regulations in the following areas:

  • Documentation and Control of documents
  • Management Responsibility
  • Resource Management
  • Product Realisation
  • Measurement Analysis and Improvement
  • Risk Management
  • Traceability and UDI
  • Vigilance

Kinesys can help implement an ISO 13485 system that is right for your organisation, based on size, complexity and risk profile of your device or service. We have experts in process design and QMS requirements that will ensure your quality systems work seamlessly with your business processes. 

Activities and experience include:

  • Full QMS implementation 
  • Process or device specific consultancy
  • ‘Certification Recovery’ for organisations whose existing system has experienced systematic failure (ISO 13485 certificate loss, suspension or lapse)
  • Corrective action consultation including root cause analysis