Find the gaps in your QMS, before they’re critical.

Regulatory Affairs Consulting

Our mock audits and gap assessments test QMS and technical documentation readiness — including unannounced audit scenarios — before your real notified body visit.

Technical documentation for some device classes is based on sampling. You prepare everything to your procedures, and the Notified Body selects a device to assess. Why wait until the audit to evaluate compliance? Let us find the gaps before your notified body does.

Or maybe you haven’t received an unannounced audit yet, and want to prepare for the day. We can organise a mock unannounced audit to be as close to the real thing as possible, to test your response.

  • Auditors aren’t there to catch you out. Their job is to find evidence that your company meets the requirements of relevant laws and standards.

    They’ll always follow an audit trail, starting from a plan that they should share with you in advance.

    An audit trail is flexible, allowing an auditor to dig into potential issues, and closing when they are satisfied with the documentation.

  • If it’s your first ever audit, you need to establish a QMS in line with ISO 13485:2016+A11:2021.

    It must have more than procedures - you need records for design, purchasing, manufacturing, sales and distribution, management and post-market processes. The records should show the QMS functioning as intended.

    It’s not wrong to make mistakes, but the QMS should detect and handle them.

  • A QMS audit looks at the whole company through a lens of ISO 13485. The auditor will look at technical documentation, but not in great detail.

    A technical documentation audit focuses on a single device (or small group of very similar devices), with an auditor that has experience in the design and manufacture of that specific device type. They’ll work through the General Safety and Performance Requirements (EU MDR Annex I, EU IVDR Annex I) line by line, reviewing your technical reports, to confirm that they have been met.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

DIRECTOR

Bio

What better way to test your documentation, procedures and people than by a mock audit with a former notified body specialist?

This is the ultimate preventative control.

Every engagement is unique, and we tailor a bespoke set of deliverables to every project.

Services

  • Mock quality management systems (QMS) audit - to ISO 13485, EU MDR and/or UK MDR

Pre-arranged, on-site audit. Duration varies by QMS scope and the size of the company. You can choose whether to inform your team that it is a mock audit.

  • Mock technical documentation audit - to EU MDR and/or UK MDR

Pre-arranged, remote or on-site audit. Duration varies by device type and classification. You can choose whether to inform your team that it is a mock audit.

  • Mock unannounced audit

Arranged with a very limited team (e.g. CEO and Head of RA), to retain the element of surprise and test the response. 1 day onsite.

  • Mock subcontractor audit

Pre-arranged audit at the subcontractor site. Duration varies by the scope of activities and the size of the subcontractor facility. You can choose whether to inform your subcontractor that it is a mock audit.

EXAMPLE DELIVERABLES

  • Audit report

  • Gap closure recommendations

  • Audit skills coaching

  • Management recommendations

For a More Prepared Future

  • How to be audited

  • EU MDR

  • GSPRs, clause by clause

  • Technical documentation writing skills

Training

  • Review & improve procedures for unannounced audit

  • Review & improve procedures for subcontractor management and audit

Management Consulting

  • Audits for medical device typically fall into four categories:

    • Quality systems audit

    • Microbiology (sterility) audit

    • Technical documentation assessment

    • Unannounced audit

    Some EU notified bodies combine elements, for example sending an auditor that is qualified on both QMS and microbiology.

  • EU notified bodies perform unannounced audits. These were originally required under Commission Recommendation 2013/473/EU, in response to the PIP Breast Implant scandal. The requirement for unannounced audits has since been embedded in the EU MDR (and IVDR).

    For devices sold in the UK, Approved Bodies are the equivalent since Brexit. In an ideal scenario, you will have picked an organisation that has both an EU Notified Body and UK Assessed Body, and can therefore conduct a combined unannounced audit.

    Countries in MDSAP (medical device single audit program) generally have retained the option to perform unannounced audits “for cause” – therefore you could have an unexpected visit from the US FDA or Health Canada, if they have a specific concern.

  • Yes. This is an approach taken by the EU and UK in particular, relating to the original Commission Recommendation 2013/473/EU (when the UK was still part of the EU).

    The underlying principle of that recommendation, and current practice, is that the legal manufacturer should have appropriate control of its subcontractors and suppliers (via quality agreement and inspections), and notified bodies are within their rights to audit this.

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