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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Services

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

General

EU/CE Marking

US FDA

Global

Regulatory strategy

Our regulatory strategies can cover the entire development and marketing of the device or focus on specific subjects such as changes to a device or the regulatory requirements. Starting from defining whether the product meets the definition of a medical device in the geographic location, determining which regulations and standards apply and laying the foundation to the testing strategy required, a regulatory strategy is a great way to kick off a project and avoid any unpleasant surprises.

Classification determinations

We can provide classification determinations for devices in any geographic location, whether it is through reviewing the classification rules in the EU, Canadian or Australian medical device regulations or searching the US FDA device classification database, our determinations are based on years of experience implementing the classification rules and provided with sound justifications for the choice.

Most classification determinations are relatively straightforward to make but some require a careful review of guidance documents, decisions reached for other similar devices on the market or legal proceedings where similar issues have been considered.

Risk Management Files (ISO 14971)

Risk is a factor that is relevant to every aspect of the medical device lifecycle, so a well-constructed risk management file is likely to save considerable effort in any project. We can construct or update a risk management file using a range of different formats and techniques such as failure modes and effects analysis (FMEA) or fault tree analysis (FTA).

Biological Evaluation Plans and Reports (ISO 10993)

For any device that has direct or indirect contact with a patient or user, a comprehensive biological evaluation plan and report will enable speedy regulatory approvals and minimise any complaints of adverse events during use. Our consultants have specialist knowledge and training on conducting biological evaluations, ensuring that any potential toxicological effects are identified and analysed quickly and efficiently.

Medical Device Regulation (MDR) transitions

With the delayed implementation date of the MDR fast approaching and the limited time afterwards when medical device directive (MDD) certificates will still be valid, it is important to implement an up-to-date strategy for making this transition. Whether it is identifying deficiencies in technical files, clinical data or quality management system requirements, we can perform a full review to identify these gaps and help identify the most efficient way to fill them.

IVD Regulation (IVDR) transitions

Due to the scale of the changes imposed by the IVDR, it is important for manufacturers to have in place a detailed plan which lays out exactly what work is required to maintain compliance and not jeopardise future sales. We use our expertise in IVD regulatory requirements to provide a comprehensive scheme for helping manufacturers transition to the new IVDR.

Technical File/Technical Documentation

One of the best ways to ensure speedy market access is to produce a clear and comprehensive set of technical documentation for the regulatory authority or notified body to review. Using the latest guidance, we can help ensure that all of the required information is present and is arranged in a way that is quick and easy to find and understand, reducing review times and costs and leading to faster approvals.

Clinical Evaluation Plans and Reports

We can provide clinical evaluation plans and reports to meet the requirements of the MDD or MDR and relevant guidance documents, whether the clinical evaluation is based on clinical data available on the device itself through clinical trials and post market surveillance or through data obtained from a literature review of equivalent devices. This includes leading or supporting the work required to demonstrate equivalence to other devices on the market.

Most clinical evaluations are able to obtain sufficient clinical data to demonstrate the safety and performance of the device, through leveraging all available data, using the best literature search methodology and the use of justifications for not requiring clinical data for certain low-risk devices with a simple interaction with the patient. However, when a gap in the clinical data exists, we can also advise on the most effective and efficient method for collecting the data to fill that gap.

Post market surveillance

With the introduction of the MDR and IVDR, the focus on post market surveillance has increased substantially. Our understanding of the relevant requirements and experience in how to best meet them means that we can help devise the most appropriate post market surveillance plan and post market clinical follow-up (PMCF) plan for the situation. This can be through leveraging existing avenues of collecting PMS and PMCF data as well as constructing bespoke studies to fill in any gaps in safety or performance data in the most efficient way possible.

Substantial/significant change determination

Many manufacturers tend to overreport changes to their certifying notified body, often due to overly cautious advice from that notified body. However, a careful, independent determination on whether the change is substantial may lead to avoiding unnecessary reviews and the associated cost, project delays and loss off flexibility.

Person Responsible for Regulatory Compliance

A requirement of the MDR and IVDR is that a manufacturer has at their disposal a PRRC, who has a number of responsibilities and competency requirements. For smaller organisations, this person can be outside the company and in these cases we are able to take on that role. For larger organisations we can be on standby for issues where the in-company PRRC would like some additional advice or a second opinion, with the added advantage of helping demonstrate the required competence of the PRRC.

510(k) Premarket notification

We can assist in all areas of compiling and submitting 510(k)s for marketing relevant devices in the US, from the careful selection of predicates and, where necessary, reference devices, and determining appropriate testing, through to compiling the 510(k) and responding to any requests for information from the FDA reviewer.

De Novo applications

For devices where no predate exists for use in a 510(k) but which are not high enough risk that they should be in class 3, a De Novo submission can be a useful way to progress to market. While it is similar in ways to a 510(k), the data requirements are generally higher and clinical data are more likely to be required. In addition, a justification for the proposed classification of the device must be provided. We have much experience in using this pathway and can use this to support projects where a De Novo is an appropriate route to take.

Pre-submission review meetings

The FDA pre-submission process can be very useful for initially engaging the FDA and obtaining feedback on any pertinent questions on the development and regulatory review of the device. We are able to help plan and execute the application for a pre-submission meeting, ensuring that the correct information is provided and the right questions are posed in order to obtain the desired feedback.

Global registrations

We can work with any in-country representatives to be able to decipher any requests from regulatory agencies and provide the most relevant information that is available. We have recent experience in assisting registrations in many territories across the globe, including the following: Australia, Canada, China, Japan; India, Brazil, Middle East


 
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.
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