Medical device post-market surveillance services POST MARKET INSIGHTS

Real-world clinical feedback. Regulatory evidence. Commercial intelligence.

Helping medical device manufacturers understand how their products perform in everyday clinical practice through structured healthcare professional engagement and actionable real-world insight.

A collaborative service from Med Dev Services and Wound Care People.

Discuss Your Post Market Requirements Explore Our Approach
James Saunders, founder of Med Dev Services

James SaundersFounder, Med Dev Services. Commercial and strategic lead for Post Market Insights.

Post-market surveillance should not simply tell manufacturers whether something has gone wrong. It should help them understand how their products are actually performing, what clinicians think and where there are opportunities to improve.
Med Dev Services
Brings the commercial understanding.
Wound Care People
Brings the clinical access.
Together
We help manufacturers turn real-world clinical feedback into evidence, insight and action.
The challenge

The gap between regulatory responsibility and real-world clinical insight.

Manufacturers must monitor how their devices perform once they reach the market. Yet many have little direct contact with the healthcare professionals who use those devices every day.

Limited direct access to clinicians

Products reach patients through wholesalers, distributors and supply contracts, leaving little direct contact with the clinicians who use them.

Fragmented post-market information

Complaints, sales teams, distributors and literature each hold part of the picture. Turning it into a coherent view of performance is hard.

Reliance on reactive complaints

Feedback typically arrives only when something has gone wrong. Everyday experience of how products perform goes largely unrecorded.

Little commercial insight

PMS data is rarely structured to answer commercial questions about user preference, competitor performance or unmet clinical need.

You cannot fully understand product performance if you cannot access the people using your products.

Distribution channels, intermediaries, GDPR considerations and limited clinical engagement all widen the gap. Post Market Insights is designed to help close it.
Why now?

Post-market surveillance is evolving. Your approach should too.

Regulators in Great Britain and the EU expect manufacturers to monitor safety and performance proactively, not simply respond to complaints. The two regimes are closely aligned but legally separate.

Great Britain

UK Medical Devices Regulations 2002, as amended

New post-market surveillance requirements (Part 4A) have applied since 16 June 2025 to UKCA- and CE-marked devices placed on the market in England, Scotland and Wales, proportionate to device risk class.

  • A device-specific PMS system and PMS plan for collecting and evaluating post-market information.
  • Review of complaints and feedback to identify emerging risks and trends.
  • Serious incident and trend reporting to the MHRA within defined timescales.
  • Preventive and corrective action, including field safety corrective actions where needed.
  • Periodic PMS reports or PSURs, with content and frequency set by risk class.
  • Retention of PMS documentation, available to the MHRA on request.

EU MDR continues to apply in Northern Ireland.

European Union

EU Medical Device Regulation (EU) 2017/745

Applies to devices placed on the EU market and in Northern Ireland. Post-market obligations sit mainly in Chapter VII, with clinical evaluation in Article 61 and Annex XIV.

  • Article 83: a PMS system proportionate to risk class, integral to the quality management system.
  • Article 84: a PMS plan, forming part of the technical documentation (Annex III).
  • Article 86: Periodic Safety Update Reports for class IIa, IIb and III devices. Class I devices prepare a PMS report under Article 85.
  • Article 87: reporting of serious incidents and field safety corrective actions.
  • Article 61 and Annex XIV Part B: post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation, where applicable.

EU PSUR frequencies and Notified Body review routes do not automatically apply in Great Britain.

Your existing PMS sources

  • Complaints and incident reports
  • Distributor and sales feedback
  • Literature and registry data
  • Structured clinician feedbackAdded by Post Market Insights
Your PMS system

Evaluated by you, under your own PMS plan and quality management system

Informs

  • PMS reports and PSURs
  • Clinical evaluation and PMCF
  • Risk management
  • Product and commercial decisions

This summary is for general orientation only and is not legal or regulatory advice. Manufacturers remain responsible for their own compliance. Refer to the MHRA post-market surveillance guidance, SI 2024/1368 and Regulation (EU) 2017/745. Last reviewed November 2026.

Our solution

One service. Two complementary outcomes.

Post Market Insights adds a structured, proactive route to real-world clinical feedback from healthcare professionals. The same evidence that supports your PMS activity can also sharpen your commercial strategy.

Outcome 1

Regulatory and clinical evidence

Strengthen your post-market data with documented feedback from clinicians who use your products in routine practice.

  • Supports your post-market surveillance activities
  • Generates structured clinical feedback on a planned basis
  • Supplements complaint, vigilance and distributor data
  • Contributes to clinical evidence development and PMCF activity
  • Documented outputs to inform PMS reports and technical documentation
  • Supports ongoing evaluation of safety and performance

Outputs are designed to be evaluated within your own PMS system. They complement, rather than replace, your wider regulatory obligations.

Outcome 2

Commercial and product intelligence

Understand how clinicians really experience your products, and where the opportunities lie for growth, differentiation and innovation.

  • Genuine insight into product performance in practice
  • Identification of unmet clinical needs
  • Competitor strengths and weaknesses, from the user's perspective
  • Evidence to support differentiation and product development
  • Insight for market access, reimbursement and value-based procurement
  • A clearer view of customer experience
How it works

A clear, four-stage approach to real-world feedback.

Each project is tailored to your portfolio, device types and objectives, with each partner leading the stage that matches its expertise.

  1. Define

    We work with you to agree the products, clinical questions, evidence requirements and objectives, and design the engagement and methodology accordingly.

    Led by MDS

  2. Engage

    Wound Care People facilitates structured engagement with relevant healthcare professionals from its professional network.

    Led by Wound Care People

  3. Analyse

    Feedback is collected and interpreted to identify patterns, experiences, opportunities and any areas of concern.

    Led by MDS

  4. Deliver

    You receive structured findings and documented outputs to support PMS activity, clinical evidence and commercial decision-making.

    Led by MDS

Potential outputs

Scope and methodology are agreed at the Define stage, so outputs match what you need them to support.

  • Structured healthcare professional feedback
  • Product usage insights
  • Clinical performance observations
  • Comparative product feedback
  • Identification of unmet needs
  • Product improvement opportunities
  • Evidence summaries
  • Documented reporting for consideration within your PMS system
135,000+UK healthcare professionals in the Wound Care People network

Reach the clinicians who use your products

Access to a substantial UK healthcare professional network, enabling targeted engagement with clinicians relevant to your products and therapeutic areas.

Participation in any project depends on relevance to the device category and on each professional's preferences and consent. Findings reflect the professionals who take part and are not presented as statistically representative unless the agreed methodology supports it.

Responsible by design

Credible evidence starts with a sound, transparent methodology.

  • Data protection built inUK GDPR-compliant collection, clear participant information, consent or another applicable lawful basis, and data minimisation are integral to every project.
  • No patient-identifiable dataWe collect professional experience and opinion, not patient records or confidential case details. Feedback is handled and reported securely.
  • Clear about what evidence isStructured healthcare professional feedback can inform PMS and clinical evaluation. It is not a clinical investigation or trial evidence.
  • You stay in controlManufacturers retain responsibility for their own PMS systems and regulatory compliance. Our outputs are designed to support your evaluation, not replace it.
The partnership

Clinical access meets commercial understanding.

Two independent organisations, each bringing distinct expertise to a jointly delivered service.

Med Dev Services logo
Commercial and evidence expertise

An independent medical device consultancy founded by James Saunders, providing commercial, market access and product development support to manufacturers, distributors and brand owners.

  • Commercial strategy and market access
  • Medical device and wound care expertise
  • Interpretation of clinical and market evidence
  • Manufacturer engagement and project leadership
meddevservices.com
Wound Care People logo
Clinical engagement and access

A specialist healthcare publisher and education provider whose professional network supports structured engagement with clinicians working in real-world practice.

  • Healthcare professional access
  • Clinical engagement across relevant specialties
  • Structured real-world feedback collection
  • Targeting by role, setting and therapeutic area
woundcarepeople.com

Post Market Insights is delivered collaboratively by Med Dev Services and Wound Care People. Each organisation remains independent.

James Saunders
Led by James Saunders

About James Saunders

Post Market Insights is led through Med Dev Services by James Saunders, bringing more than 30 years of medical technology experience, extensive wound care knowledge and a practical understanding of the commercial challenges facing medical device manufacturers.

James is the commercial and strategic lead: he scopes each project with you, shapes the questions that matter to your business and interprets the findings. Healthcare professional engagement is delivered through Wound Care People.

30+
years in UK medical technology
25+
years in wound care
30+
countries worked across
£100m+
sales from brands launched and developed
More about Med Dev Services
Who should consider this service?

For manufacturers who want more from their post-market data.

Particularly relevant where products reach users through complex supply chains and direct clinical feedback is hard to obtain, as in wound care.

  • Medical device manufacturers
  • Wound care manufacturers
  • Ostomy and continence manufacturers
  • Single-use device manufacturers
  • Distributors and brand owners
  • Companies entering or expanding in UK and European markets
  • Teams preparing product launches
  • Lifecycle reviews and portfolio development
Commercial outcomes

Evidence that can do more than satisfy a regulatory requirement.

Better understanding of clinical practice

See how products are selected, used and judged in hospital and community settings.

Stronger product differentiation

Ground your positioning in what users genuinely value.

Improved development decisions

Prioritise improvements and new products with clinician feedback behind them.

Identification of unmet needs

Surface the gaps clinicians work around every day.

Insight into competitor performance

Understand how alternatives compare from the user's point of view.

Support for value-based procurement

Bring real-world user experience into tender and formulary conversations.

Better-informed market access

Build reimbursement and access plans on evidence rather than assumption.

What could your products be telling you?Start the conversation
Questions

Medical device clinical feedback: common questions.

Does Post Market Insights fulfil my post-market surveillance obligations?

No single activity can do that. Post Market Insights provides an additional, structured source of real-world clinical feedback for you to evaluate within your own PMS system. Manufacturers remain responsible for their PMS system, plan, reporting and wider regulatory compliance.

Is the feedback clinical trial evidence?

No. The service captures the structured experience and opinions of healthcare professionals who use your products in routine practice. It can inform PMS activity, PMCF planning and clinical evaluation, but it is not a clinical investigation.

Is the service only for wound care products?

Wound care is where the partnership has deepest roots, but the approach can be applied to other single-use and community-used devices, including ostomy and continence products, where relevant clinicians can be reached. We will tell you honestly at the Define stage whether it is a good fit.

Can the results support UK and EU documentation?

Outputs are documented so you can consider them within PMS reports, PSURs, clinical evaluation and risk management. Requirements differ between Great Britain and the EU, so how you use the findings in each is your decision, informed by your regulatory team.

How is data protection handled?

Data protection is built into the methodology: UK GDPR-compliant collection, clear participant information, consent or another applicable lawful basis, data minimisation, no patient-identifiable information, and appropriate secure handling and reporting of feedback.

How long does a project take?

It depends on scope, the number of products and the clinician groups involved. We agree a realistic timeline with you at the Define stage.

Get in touch

Let's understand what your products are telling you.

Whether you are reviewing your existing PMS arrangements, preparing for regulatory requirements or looking to generate better clinical insight, let's discuss how Post Market Insights could support your business.

  • An initial, no-obligation conversation with James Saunders
  • A clear view of what could be achieved for your portfolio
  • A tailored proposal if there is a good fit

Prefer email? Contact James directly at
[email protected]

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James Saunders will be in touch, usually within two working days. If your enquiry is urgent, email [email protected].

Ready to turn post-market surveillance into real-world insight?

Discuss Your Post Market Requirements