MEDICAL DEVICE MANUFACTURING

The parts of your quality system you outsource still get audited. We make sure they hold up.

In medical device manufacturing, your garments, cleaning, consumables and gowning competency aren't procurement lines. They're outsourced processes inside your ISO 13485 system and your MDR technical documentation - and under MDR, a notified body can audit them, unannounced. CWS Cleanrooms runs all of them as one validated, documented programme, so the supplier side of your file is audit-ready by default.

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THE PRESSURE

MDR raised the bar on your quality system - including the parts you don't run yourself.

You already carry the weight of the technical file, the risk management, the post-market surveillance. What's changed under MDR is how far that scrutiny now reaches: your critical suppliers are assessed directly, and the evidence has to be there on demand. Most device manufacturers are managing four pressures at once, and each one lands back on the same desk.

	MDR made your suppliers part of the audit Notified bodies can now assess your critical suppliers directly, and arrive unannounced. A gap in a supplier's process isn't their problem to explain at your audit - it's yours, and it can hold up your CE marking.
	Sterilisation only holds if bioburden stays low Most devices are terminally sterilised. Your environment, gowning and consumables set the bioburden load your EtO, gamma or steam cycle has to overcome - which makes the cleanroom part of your sterility assurance, not a step before it.
	The stakes scale with your device class Class III, implantable, active implantable. Here a contamination event isn't lost yield - it's a patient-safety trace that runs straight back into your risk file, where every control has to be justified.
	Personnel are still the primary source People shed particles and microorganisms. Gowning, behaviour and competency are the largest contamination risk you can actually control - and the hardest to evidence consistently across shifts, lines and campaigns.

WHERE IT LIVES

The parts of your quality system a supplier delivers - we stop treating them as deliveries.

Most device sites buy garments from one company, consumables from another, cleaning and training from two more. Each is fine on its own. The exposure sits in the space between them, where no single supplier is accountable for how the pieces hold up under audit. CWS Cleanrooms runs those parts as one governed programme, so each arrives as documented QMS evidence rather than a product you then have to make compliant.

Garments & gowning

Validated laundering and sterilisation, item-level lifecycle control, and gowning qualification evidence - the record your file needs, supplied with the garment.

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Cleaning & disinfection

Documented, audit-ready and mapped to your classified areas. A cleaning process inside your quality system, not a service you supervise.

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Consumables

Validated supply, vendor-managed to your usage, so the right qualified item is on the shelf - delivered with the bioburden, particle and sterility data your validators need in hand.

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Training & Competency

Role-based training that turns gowning and behaviour protocols into consistent floor habits, with the competency records to prove it.

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On-site service

A team embedded at your facility, closing the gap between delivery and the point of use, where most contamination risk actually enters.

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One contract

Every service on a single agreement - negotiated once, renewed once. No patchwork of terms, renewal dates and price lists to keep track of.

One contact

A single named person who owns the whole programme. When something needs resolving, there's no triage between suppliers you make one call.

One fixed rate

Pricing built around your actual volumes and procedures, fixed for the term. Full budget visibility, with no reactive premiums.

One data layer

Usage, compliance and cost across every service in one view - so the patterns hidden across four suppliers become visible in one.

START WHERE YOUR PRIORITY IS

Come in through your biggest risk. The rest is already connected

Wherever your risk sits right now, there's a route in - and they all draw on the same foundation. Contamination control and continuity are focused entry points; Integrated Cleanroom Management is the full programme they're part of. You don't have to take all of it at once to get the benefit of how it fits together.

SOLUTION 1
Contamination control

Bring particulate, microbial and gowning control under one measurable strategy instead of managing each risk in isolation - the control set your ISO 13485 environment and your auditors expect to see governed together.

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SOLUTION 2
Cleanroom continuity

Supply engineered around your production logic, because a stockout of qualified garments or consumables in a classified area isn't a late delivery - it's a change-control event inside your quality system.

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THE FULL PROGRAMME
Integrated Cleanroom Management

All five services under one contract and one point of accountability.

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YOUR DEVICE

From implantables to diagnostics - matched to your class and your risk.

Our customers already span the device spectrum. The programme scales to the criticality of the area it protects: the higher the class, the higher the tier. For Class III and implantable areas, that means a defined minimum stock, a recovery-time objective agreed with your quality team, and a qualified backup pathway - so protection tracks your actual risk, not a standard delivery frequency.

Implantable devices · Class III

The highest sterility and particulate demands in medtech, in ISO 5–7 environments. This is the tier where a single gowning gap or stockout is least tolerable -so it receives the highest level of protection.

Sterile medical devices

Surgical instruments, catheters and IV sets in ISO 7/8. Disinfection- and gowning-intensive, with validated cleaning and garment evidence carrying real weight at ISO 13485 audit.

Active implantable & electronics

Pacemakers, neuromodulation and similar devices in ISO 7, where particulate control is as critical to function as it is to compliance, and consistency across the build matters.

In-vitro diagnostics

Reagents, assays and test kits produced in controlled environments under IVDR, where contamination-free production protects both the result and the patient who depends on it.

Single-use & combination products

Prefilled syringes, autoinjectors and other drug-device combinations, where the device sits under MDR and the drug side pulls in GMP. We run both worlds under one programme - the place our pharmaceutical and device experience meet.

THE EVIDENCE

What we promise up front is what your notified body finds.

Every claim is backed by a certificate, not an adjective. We're certified to ISO 13485, so the way we work is built for your regulatory world, not adapted to it. Garments leave validated - sterilisation revalidated annually against three test organisms, with a reduction of at least seven log stages - and the batch documentation arrives with the delivery. Consumables ship with material traceability, bioburden, CFU, particle counts and sterility validation, so the numbers your file needs are already in hand. And we keep a site-specific evidence pack current for your programme, ready to produce when an assessor asks, announced or not.

98.7^%

on-time, in-full delivery, so continuity is a measured commitment

95-100^%

of garment-related audit non-conformities prevented

80^%

fewer urgent reorders once supply is engineered to your usage

MAKING THE CHANGE

Changing a validated supplier means change control. We arrive with the paperwork already done.

For a device site, the fear isn't the idea of an integrated programme - it's the change control and re-qualification it seems to trigger, and the audit risk while it's in flight. We've done this enough times to take that load off your QA team. You get pre-built change-control documentation ready to slot into your QMS, validated certificates and qualification data on request, and a reference from a validated customer who has already made the move. Where it helps, we start with a pilot that doesn't need full change control to begin. Your cleanroom doesn't stop while we start.

13–25 days
Sign-up

Service configuration, pricing and contract, with programme goals and change-control scope documented before anything moves.
30–60 days
Onboarding

Services set up, starting volumes confirmed, on-site staff hired and in place, validation documentation handed over.
Ongoing
Execution

Programme live, quarterly business reviews, continuous adjustment as your operation and your product mix evolve.

Let's look at where your file depends on a supplier - and whether that evidence would hold up on audit day.

Bring us your current setup. A specialist who works in nothing but cleanrooms will show you where the supplier-side exposure sits, and what audit-ready by default would take for your site. No commitment.

Speak to a Specialist

The parts of your quality system you outsource still get audited. We make sure they hold up.

MDR raised the bar on your quality system - including the parts you don't run yourself.

The parts of your quality system a supplier delivers - we stop treating them as deliveries.

What "one programme" actually means.

One contract

One contact

One fixed rate

One data layer

Come in through your biggest risk. The rest is already connected

From implantables to diagnostics - matched to your class and your risk.

What we promise up front is what your notified body finds.

Changing a validated supplier means change control. We arrive with the paperwork already done.

Sign-up

Onboarding

Execution

Let's look at where your file depends on a supplier - and whether that evidence would hold up on audit day.