Design & Development

From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.

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Services

We have expertise and offer support in many areas, including the following:

Design Inputs

During a design and development or design control process, arguably the most important stage is correctly defining the design inputs for the device. These should be comprehensive and unambiguous so that they fully cover all user needs of the device and so that they can be clearly demonstrated through verification testing. We have extensive experience in helping to define design inputs for a wide range of devices and this means that we can ensure that the development project runs as smoothly as possible.

Biological evaluation

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. Many test companies will suggest an overly thorough set of tests to conduct, often involving animal testing, whereas we have the expertise to be able to provide an independent testing plan, focussing on the relevant tests for characterising the materials and leveraging any existing safety data to help avoid costly and ethically challenging animal testing.

Usability engineering/human factors studies (IEC 62366)

Due to the number of use errors occurring with medical devices, 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, starting with an initial hazard analysis to determine which stages of use require further investigation, through to helping to define any formative or final summative evaluations that need to be conducted.

Clinical investigations/studies

When developing a novel device or if there are insufficient clinical data available on any equivalent devices, 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 defining acceptance criteria and sample sizes, have been made.


 
Providing regulatory and quality solutions to the medical device industry
Providing regulatory and quality solutions to the medical device industry

Our Expertise

 

Regulatory Affairs

We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase. Our insight into the regulatory requirements will pave the way for a smoother route to market.
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Quality Assurance

Whether you are looking for assistance with internal audits and CAPAs or to delegate the running of your entire quality management system, we can provide the most appropriate solution to help.
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Design & Development

From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.
Read more »