Medical Device Consultant Support for UK & EU Regulatory Challenges

Clear regulatory direction for medical device and IVD teams that need more than generic advice.

SciMed supports manufacturers across the world with scientifically grounded, decision-ready regulatory consultancy support. Whether you need help with clinical evidence, classification, post-market obligations, technical documentation, risk management, or Notified Body interactions, we help you define the right path and move forward with confidence.

Book a 30-Minute Discovery Call
Book a 30-Minute Discovery Call
[Bray Group]
[Caristo Diagnostics]
[C the Signs]
[CooperVision Specialty EyeCare]
[Innovia Medical]
[LifeScan]

Trusted by MedTech Teams Who Need Clear Next Steps

Specialist support for manufacturers navigating evidence, compliance, submission readiness, and lifecycle obligations.

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    “SciMed were able to decipher the MDCG guidance and translate it into what the documentation should look like for auditors.”

    James Davis - Head of Quality and Regulatory; Caristo Diagnostics

  • "We’ve got great confidence going into audits that the documentation will meet what auditors are looking for."

    Liz Gillman - Clinical Compliance Project Lead; LifeScan

  • Headshot of a clinical director endorsing SciMed's regulatory solutions.

    “We wouldn’t be compliant. We wouldn’t be audit-ready.”

    Julie Anne Nicholson - Clinical Director, Innovia Medical

What You Can Expect from SciMed

✅ Specialist regulatory interpretation…

…grounded in current UK and EU expectations.

✅ Clear deliverables…

…that support audit readiness, submission quality, and internal decision-making.

✅ Scientific depth…

…or evidence-led services, not just procedural advice.

✅ Commercially aware guidance…

…that helps you avoid delay, rework, and unnecessary burden.

✅ Support across the product lifecycle…

…from early strategy through post-market maintenance.

✅ A credible long-term partner…

…or teams that need consistent regulatory support without overbuilding internal headcount.

Six Core Service Clusters, One Consultancy Partner

SciMed Clinical Evaluation service brand

Clinical Evaluation

For manufacturers who need CER, CEP, State-of-the-Art reviews, gap analysis, remediation, or wider clinical evidence support under MDR and related frameworks.

Best suited when you need to:

  • strengthen a Clinical Evaluation before review

  • remediate evidence gaps

  • prepare for audit or submission scrutiny

  • build a defensible clinical evidence package

SciMed Post-Market service brand

Post-Market Services

For teams managing PMS, PMCF, PMPF, PSUR, SSCP, ongoing literature monitoring, and documentation maintenance across live product portfolios.

Best suited when you need to:

  • keep documentation current

  • build a more controlled post-market system

  • reduce recurring internal burden

  • create a sustainable maintenance model

SciMed Performance Evaluation service brand

Performance Evaluation

For IVD manufacturers who need structured scientific and regulatory support for performance evidence, including PEP, SVR, PER, and related documentation.

Best suited when you need to:

  • define an IVD performance evidence strategy

  • prepare evaluation documentation

  • address weaknesses before review

  • improve confidence in your evidence position

SciMed Risk & Biological Evaluation service brand

Risk & Biological Evaluation

For manufacturers who need support with Risk Management documentation, Biological Evaluation strategy, and the wider logic behind safety justification.

Best suited when you need to:

  • strengthen your risk file

  • define a sensible biological evaluation approach

  • align documentation across safety and performance

  • avoid inefficient or poorly scoped testing pathways

SciMed Regulatory Strategy service brand

Regulatory Strategy

For teams making early route-to-market decisions, preparing technical documentation, or clarifying qualification and classification before costly downstream work begins.

Best suited when you need to:

  • define your regulatory pathway

  • prepare classification or qualification rationales

  • scope technical documentation requirements

  • make better early-stage compliance decisions

SciMed Notified Body & Market Access service brand

Notified Body & Market Access

For manufacturers preparing for difficult submissions, unclear reviewer feedback, broken Notified Body interactions, or expansion into additional markets.

Best suited when you need to:

  • interpret or challenge reviewer feedback

  • prepare for meetings or responses

  • resolve stalled market access progress

  • plan expansion into new territories

Not sure which service cluster applies?

Book a 30-Minute Discovery Call
Book a 30-Minute Discovery Call

Start with a focused discovery call and we can help you identify the right next step.

Why Manufacturers Bring in Specialist Regulatory Support

Most regulatory problems do not begin as obvious failures. They begin as unclear decisions, weak assumptions, or documentation that does not fully align.

  • An unclear classification affects the route to market,

  • A weak clinical evidence strategy creates review risk,

  • Disconnected technical documentation leads to rework,

  • Underdeveloped post-market systems create audit pressure later,

  • Difficult Notified Body feedback slows progress and strains internal teams.

The longer these issues remain unresolved, the more expensive they usually become.

Why SciMed, Rather than a Generalist Consultancy

Scientific Authority Where it Matters

SciMed supports manufacturers with regulatory work that requires more than procedural knowledge.

This includes areas where decisions must be justified, evidence must be interpreted, and documentation must stand up under scrutiny..

Clear Outputs that Support Confident Regulatory Decisions

SciMed focuses on producing work that can be used, not just used to tick a box.

Each deliverable is structured to support internal decision-making, external review, and ongoing compliance requirements.

A Consultancy Partner that Supports you Beyond a Single Project

Regulatory needs rarely exist in isolation.

Many engagements begin with a defined task but extend into wider support as requirements evolve across the product lifecycle.

SciMed works with clients in a way that allows continuity, consistency, and long-term regulatory confidence.

Are SciMed the Right Fit?

Our approach is typically suited to teams who:

  • Need clear regulatory direction, not vague advice,

  • Are managing a high-stakes submission, audit, remediation, or route-to-market decision,

  • Want specialist support grounded in scientific and regulatory reasoning,

  • Need a partner who can work across evidence, documentation, and lifecycle obligations, or

  • Values clarity, quality, and defensible outputs.

It may be less suitable if:

  • Are only looking for the cheapest available provider,

  • Want minimal strategic input,

  • Want a consultant to validate a decision without challenge, or

  • Do not need detailed reasoning or high-quality documentation support.

Case Study Preview

Featured
Lifecycle Compliance: Maintaining MDR & IVDR-Ready Documentation
Lifecycle Compliance: Maintaining MDR & IVDR-Ready Documentation

Getting Clinical and Performance Evaluation documentation across the line is one challenge. Keeping it there is another entirely. Learn how LifeScan partnered with SciMed to turn compliance maintenance from a reactive scramble into a predictable, structured lifecycle process so their team is always ready when regulators come knocking.

Read More →
Building Sustained MDR Audit Readiness
Building Sustained MDR Audit Readiness

Innova moved from regulatory risk to sustained MDR audit readiness by remediating hundreds of clinical documents and restoring confidence across the business. This case study explores how a pragmatic regulatory partnership with SciMed helped stabilise compliance and reduce notified body friction.

Read More →
Navigating Regulatory Classification with Confidence
Navigating Regulatory Classification with Confidence

See how C the Signs established a clear, defensible regulatory pathway for UKCA and CE marking without hiring internal regulatory staff. By partnering with SciMed, they secured dual-market classification rationales, reduced in-house burden, and accelerated compliance timelines; freeing their team to focus on innovation, not interpretation.

Read More →
Achieving EU MDR Compliance at Scale
Achieving EU MDR Compliance at Scale

Discover how Caristo Diagnostics have been achieving seamless EU MDR compliance since 2019 without hiring internal clinical staff. By partnering with SciMed, they secured 100% CER approval rates, streamlined updates, and reliable audit readiness; while focusing their resources on innovation, not regulation.

Read More →

Our Regulatory Specialists

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    Selina McHarg - Senior Analyst

    Selina works across both MDR and IVDR projects, with particular depth on in vitro diagnostics where her molecular and biochemical research background translates directly into questions of intended purpose, analyte behaviour, and clinical decision impact. She combines a PhD in physiology with over a decade of academic research and regulatory experience spanning clinical and performance evaluation, post-market surveillance, and technical documentation.

  • Nicola Edwards - Senior Analyst

    Nicola focuses on software, combination products, and emerging technologies where the regulatory position is often non-obvious, spanning Rule 11 SaMD cases, cell and gene therapy, and drug delivery systems. She combines a PhD in Translational Cardiovascular Science with training in software and AI devices, supporting manufacturers of novel products from clinical evaluation through to technical documentation.

  • Headshot of a clinical director endorsing SciMed's regulatory solutions.

    Nadhim Bayatti - Senior Analyst

    Nadhim's focus sits on legacy devices and well-established technologies, where historic regulatory positioning and decades of existing evidence need re-examining against current MDR and IVDR expectations. He brings over two decades of postdoctoral research in neuroscience and molecular biology, alongside a PhD in Developmental Neuroscience, enabling careful interpretation of complex or long-standing evidence bases.

  • Sylvia Lui - Clinical Reviewer

    Sylvia Lui - Clinical Affairs Reviewer

    Sylvia supports the review and validation of deliverables before submission, checking that scientific reasoning, regulatory alignment, and internal consistency hold together under scrutiny. She combines a PhD in genomics and reproductive biology with extensive postdoctoral research in immunology and maternal–fetal health, strengthening the scientific integrity of each project.

Leadership & Project Oversight

  • Headshot of a senior regulatory leader supporting SciMed's medical device expertise.

    Alastair Selby - Founder & Regulatory Consultant

    Alastair leads regulatory strategy, client engagement, and oversight across all SciMed projects, with over a decade of consultancy experience serving manufacturers across the full MDR and IVDR scope and particular specialism in borderline products, pharmaceutical-to-device reclassification, and combination products. He holds positions on BSI Technical Committees CH/194 (biological and clinical evaluation) and CH/210 (quality management), and contributes to UK governmental policy on medical device regulation through the All-Party Parliamentary Group on Access to Medicines and Medical Devices.

  • Anna Le Fevre - Business Manager

    Anna oversees project coordination, financial operations, and client communication across engagements, ensuring delivery is structured, efficient, and well-managed throughout. With over 10 years' experience in accounting and audit environments, she supports consistent execution and a high-quality client experience.

Start with a 30-Minute Regulatory Discovery Call

This call is designed to help you clarify your current regulatory position, identify the most relevant service area, and understand the most sensible next steps.

On the call, we can discuss:

  • Your product and current stage

  • The regulatory issue or uncertainty you are facing

  • Which service cluster is most relevant

  • Whether a defined project or broader support is likely to be needed

There is no obligation to continue after the call.

Book Your Discovery Call
Book Your Discovery Call

We work with a limited number of projects at any one time to maintain quality and consistency.