Regulatory strategy is where commercial success begins.

REGULATORY AFFAIRS CONSULTING

Regulatory pathways are complex. Considering multiple products, multiple markets - this adds to the regulatory blur.

Decisions made early in projects can impact regulatory timelines too - each regulator has guidance and expectations for data - particularly clinical evidence.

Our regulatory strategy services can help set you on the right path for your start-up, spin-out, new product, line extension, or change submission.

  • Establish a documented quality management system in line with ISO 13485:2016+A11:2021. You’ll need procedures and records - evidence not just that the QMS exists, but that it works.

    Apply to a certification body for assessment. The choice of certification body matters; if it is also an EU Notified Body, it will also be able to perform audits for CE marking.

  • CE certificates are issued by EU Notified Bodies. These are private companies that have been designated by EU health authorities as having staff with the right competencies.

    You’ll need to apply for CE certification - budgeting enough time, resource and cost for the project. If you’re not sure what that looks like, we can guide you through the process.

  • For the EU, use EU MDR Annex VIII, or EU IVDR Annex VIII, in conjunction with the relevant MDCG guidance.

    Classification can be complex, and significantly impacts the route to market. We highly recommend discussing classification before you begin work on technical documentation.

A young man wearing glasses and a light blue dress shirt, smiling and standing against a plain beige wall.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

BIO

“Regulatory strategy is under-valued, but is a cornerstone of a successful medtech company, whether it be a start-up or multi-national.”

- Joseph Langley

DELIVERABLES

Whether your project is a new product introduction, line extension, manufacturing relocation, rebrand or anything else, typical deliverables will be:

  • A documented regulatory plan

  • A presentation to marketing or the product manager outlining and explaining the plan

  • A strategy for pre-clinical and clinical data

  • Identification of key project risks, and mitigation recommendations

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

SERVICES

FOR A MORE PREPARED FUTURE

Training:

  • For your RA team: Advanced regulatory strategy

  • For your commercial teams: Understanding regulatory strategy

Management:

  • Full NPD process flow evaluation

  • Gap analysis of RA roles & skills

Ready to set your course?

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QUESTIONS & ANSWERS

  • Clear strategy and planning for regulatory affairs (RA) - which comes from knowledge and experience.

    For start-ups, it can be hard to obtain the right staff internally for RA. This is where engaging a consultant can be highly beneficial. You get expert level guidance, whilst not committing to additional permanent payroll.

    For SMEs and multinationals, regulatory strategy remains essential for robust product launch plans. Some companies have clear internal responsibility for regulatory strategy, but others don’t. If you need assistance with strategy for a specific product, or to develop this capability internally, get in touch.

  • This has become less clear since the implementation of the new EU Regulations.

    Clinical data is often considered to be the limiting factor. The old view was that, for many devices, the bar for clinical data was lower in the EU, and therefore marketing in the US first was more viable. Some people argue that this has switched since the new EU Regulations.

    We argue that it varies significantly between different types of devices, their novelty, risk profile, and intended patient population. This should be considered in detail in the regulatory strategy for the device.

  • It’s never too soon to plan your regulatory journey.

    There are several critical factors that need to be determined early, and will be highly impactful on later decisions and resource commitments. These include:

    • Who will be the legal manufacturer?

    • Which markets are commercially desirable?

    • What is the classification of the device in those markets?

    • What are the assessment routes for that classification?

    • What are the clinical data expectations in those markets?

    We can offer a low commitment consultation service to set you on the right path in the early phases of a start up.

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Page last updated: July 2026.