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Design reviews are integral to design controls when developing medical devices such as surgical tools, diagnostic products, device – drug combination products, or general medical equipment. They are mandated in 21 CFR 820 and EN ISO 13485. 

Attendees must include representatives from the functions concerned with the tasks and activities of the closing phase plus any other specialists that may be required. An independent reviewer is mandated by some regulators including the FDA. 

Often design reviews are scheduled in the project plan at the stage gates, to confirm readiness to proceed. 

Additional reviews may occur mid-stage, ahead of a key milestone, whereas in other situations fewer may suffice with two or more phases being covered by a single, combined review.

We will ask you about your objectives first, to help form an effective overall plan with a structured approach. 

We review the documentation pack in advance and engage with your team in a friendly, professional way to understand the design approach, current focus of activities, and any emerging risks. 

We prepare a range of questions for the review meeting, aiming to derive an informed view of the maturity of the design and readiness of the project to proceed to the next stage. 

The documentation pack comprises the technical file or design history file plus the relevant, applicable procedures of your quality management system (QMS).

If your QMS mandates specific templates be used to create quality records, please include these so that we can confirm compliance. 

For combination products such as prefill syringes, vial kits, or injector pens, we aim to complete the review within 10 days from receipt of access to the documentation pack, subject to the team’s availability and readiness. 

Much of the review is carried out offline, but we will likely need to engage with your team periodically during the preparation. Allow up to 4 hours for the design review meeting itself. 

For surgical, diagnostics, or medical equipment design reviews, an initial conversation on scope would be needed.

All customer data including technical files or design history files that we review or handle in the course of our business will be treated as confidential information. We take confidentiality seriously and will not seek to take advantage of the content. 

Normally a confidentiality agreement will be put in place ahead of any detailed discussions or receipt of files.

Sure! Please contact us for an informal chat. We would be happy to explore what might best suit your needs.

We normally ask you about your objectives first, to help form an effective overall plan with a structured approach. 

Please engage with us early to confirm scope, contract and provisional dates for a design review, ideally a couple of months in advance. Contracts can take some time to set up, unless we have worked together before.

For combination products such as prefill syringes, vial kits, or injector pens, we aim to complete the review within 10 days from receipt of access to the documentation pack, subject to the team’s availability and readiness. 

For surgical, diagnostics, or medical equipment design reviews, an initial conversation on scope would be needed so that we can respond. 

We aim to reach a firm conclusion with the team by the close of the design review, such that each of the objectives agreed at the start is addressed. This includes a clear answer as to whether the design is sufficiently mature to proceed to the next development stage. For example from concept phase to detail design; from detail design to verification; etc.  

For completeness, you will receive a written summary technical report with a list of actions or recommendations and an overall conclusion. We normally prepare this shortly after the design review has concluded. 

For combination products such as prefill syringes, vial kits, or injector pens:

• We aim to complete the review within 10 days from receipt of access to the documentation pack, subject to the team’s availability and readiness. 
• Guide price £8,950 + applicable taxes, subject to agreement on scope and contract.

For surgical, diagnostics, or medical equipment design reviews, an initial conversation on scope would be needed so that we can respond with a suggested schedule and guide price.