Development

Medical Device Development Consultancy

The ever-evolving set of regulations, standards and guidelines in the field of medical device and IVD development places a high burden on companies to keep up with requirements for modern technologically advanced products.

A good Design Control system helps to identify many of the requirements and provides a logical case for the development work. This usually follows ISO 13485:2016 or US Federal Regulations:21 CFR.820 and associated guidance, but needs to be tailored to the organisation.

While QMS and Design Control provide a framework, there are more specific processes and assessments required to cover safety, performance, manufacture etc. Some of these are listed below. We help with structuring and managing these processes. We are experienced at presenting these to regulatory authorities with the scientific rigour and in the formats they expect.We can assist with the areas below, and others, in whatever way is most efficient for you:

• Biological Evaluation to ISO10993 and FDA guidance
• Risk Management to medical device standard
• Design verification and validation documentation
• Shelf life, pack and transit strategy and testing
• Electrical safety and performance testing (IEC 60601, IEC 61010)
• Software Validation (IEC 62304)
• Human factor studies (IEC62366)
• Clinical Evaluation to MDR
• Clinical Investigations
• Labelling and Unique Device Identification (UDI)
• Process validation

This can save valuable time in the development cycle and reduce the risks of rejection when a technical file or 510k is being reviewed. Below is further detail on some of the development services we provide.

Biological evaluation (previously biocompatibility)

Biological evaluation testing can often be the most expensive and time-consuming part of a development project, so ensuring it is performed correctly can be crucial for the project to stay on track. We are qualified to provide an independent testing plan, focussing on the relevant tests for characterising the materials and leveraging any existing safety data. As we’re not a pre-clinical research organisation we do not have an interest in increasing the amount of testing needed.

Risk Management Files (ISO 14971)

We construct or update risk management files using recognised formats within the ISO standard, such as failure modes and effects analysis (FMEA) or fault tree analysis (FTA).

Usability engineering/human factors studies (IEC 62366)

Usability engineering has become a focus for regulatory bodies in recent years so a sound strategy for how to address this is crucial. We can offer support in defining this strategy, from initial hazard analysis through to helping to define any formative or final summative evaluations that need to be conducted.

Clinical Evaluation Consultancy

Under the MDR these are stringent, comprehensive and, time-consuming reviews to conduct. We have extensive experience building clinical evaluation plans (CEP) and reports (CER) to meet the requirements of the MDD or MDR and relevant guidance documents.

Clinical investigations

In some cases it may be necessary to conduct a clinical study to collect safety and performance data on the device. We have assisted in conducting many clinical investigations, ranging in size from a few dozen to a few hundred patients by compiling the clinical study documentation such as the clinical investigation plan, obtaining competent authority/regulatory body and ethics approval, submitting any study change notifications and helping to write the final clinical investigation report.

Production process validation

When full testing of the product produced by a manufacturing process is not feasible, it is usually required to conduct a validation study of the process. Our experience in this area allows us to help plan and document the validation process, ensuring all of the required considerations, such as setting acceptance criteria and sample sizes, have been made.