Can Dynamics 365 help manage medical device recalls?

An FSCA depends on knowing exactly which units are involved, what components sit inside them, and who received them, and that's precisely the data both platforms hold. The FSCA and FSN process itself runs through your quality team's own procedure; Dynamics 365 supplies the traceability that procedure relies on.

Is Dynamics 365 compliant with UK medical device regulations?

UKCA marking and MHRA registration apply to your device and your quality system. Compliance is demonstrated through your organisation's validated processes, and Dynamics 365 supports that demonstration with traceability, documentation and quality records that sit alongside the regulatory work itself.

How much does medical device ERP implementation cost in the UK?

It depends on platform choice and how much validation and quality configuration your build needs. A Business Central project for a single site typically starts in the tens of thousands of pounds; a multi-site Supply Chain Management build often runs into six figures. A discovery call turns that range into a specific number for your operation.

Do medical device manufacturers need a separate quality system alongside Dynamics 365?

When design history file obligations are substantial, usually yes. The typical setup keeps Dynamics 365 running production, inventory and the device history record, while a dedicated eQMS takes on design controls and validated electronic signatures. We'll be direct about whether your operation genuinely needs that second system.

Dynamics 365 ERP for Medical Device Manufacturing

At a Glance

14+Years of Experience
150+Certified Dynamics 365 Consultants
350+Successful Implementations
Microsoft Solutions Partner
Business Central & Supply Chain Management Specialists

Microsoft Solutions Partner for Business Applications, with a Specialist designation in Small and Midsize Business Management

Why Dynamics 365 Matters for Medical Device Manufacturing

When you build a medical device, an inspector can ask at any point which batch of parts went into a specific unit, who signed off on it, and where it shipped. Dynamics 365 for medical device manufacturing puts that answer on screen in seconds, straight from the same system that runs your production floor, and the inspection stays calm and moves on quickly. Manufacturers still relying on paper files and scattered spreadsheets often spend hours digging for that same answer, turning a routine visit into a stressful scramble.

Dynamics Square recommends two products built for this job. Which one you need depends less on how big your company is, and more on how complicated your production actually is.

Dynamics 365 Business Central

Business Central suits contract manufacturers and single-site producers building a set range of devices from a bill of materials that stays largely the same.

Dynamics 365 Supply Chain Management

Supply Chain Management suits manufacturers running more than one site, working through frequent design changes, or needing formal checks in place every time something goes wrong with a part or a batch.

UKCA marking and MHRA clearance belong to your device and your own quality system. Only your organisation can earn them, through testing, checks and registration. What Dynamics 365 does is hold the data behind that work, which batch, which changes, which checks, ready the moment you need it.

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What UK Medical Device Regulations Require

Dynamics 365 for medical device manufacturing is built to keep pace with exactly these rules, so here is what UK regulation actually asks of your operation.

UK MDR 2002 and MHRA registration

Devices sold in Great Britain sit under the UK Medical Devices Regulations 2002, as amended, with the MHRA as the regulator. Every device, regardless of class, has to be registered on the MHRA's Device Online Registration System before it reaches the market. Registration confirms a device is on record; the underlying compliance work remains the manufacturer's own responsibility throughout.

UKCA marking and the CE transition

UKCA is the UK's own conformity mark, assessed by a UK Approved Body, and manufacturers based outside the UK need a UK Responsible Person to handle registration and act as the MHRA's point of contact. CE-marked devices still have a transitional route into Great Britain, though the deadlines and their possible extension are under active MHRA consultation through 2026.

Field Safety Corrective Actions

The UK's version of a device recall runs through Field Safety Corrective Actions and Field Safety Notices, reported to the MHRA through the Manufacturer's Online Reporting Environment. Under the 2024 post-market surveillance regulations, the window to report an incident expected to cause serious deterioration in health tightened from 30 days to 15.

Post-market surveillance obligations

Vigilance continues well past registration. Manufacturers have to track incident trends, investigate root causes and prove they can act quickly when a pattern emerges, obligations that sit directly on top of day-to-day production and quality data.

Traceability

Every lot and serial number gets logged the moment stock arrives or a unit comes off the line

Trace a finished device back to its individual components, or follow one component forward to every device it went into

Pull up a specific unit's history in the time it takes to run a search

Device history and documentation

Inspection results and disposition decisions attach to a unit or batch automatically as production happens

Every device carries a build history that's ready the moment an inspector asks to see it

Records that meet UK MDR 2002 expectations as a matter of course, with no last-minute scramble to assemble them

Quality management

Business Central's Quality Management module, native since the 2026 release: set up inspections, grade pass or fail, and quarantine anything that fails, right inside the core product

Supply Chain Management goes further for bigger operations, with formal non-conformance investigation, CAPA and statistical sampling built in

Supplier performance data, incoming inspection results and corrective action history, all linked back to the specific components a supplier actually sent

Production and engineering control

Multi-level BOMs and routings stay connected to production, so an engineering revision flows through to future builds automatically

MRP and MPS plan production against real capacity and what components are actually available

Every design revision stays traceable, build after build, so the current version is always the obvious one

Talk to Us About Your Manufacturing Process

Business Central or Supply Chain Management for Medical Device Manufacturing: Which ERP to Choose?

Medical device manufacturing runs as discrete manufacturing on both platforms. There's no formula or batch chemistry involved, so the decision comes down to how complex your bill of materials is, how deep your quality process needs to go, and how many sites you're managing.

Choose Business Central if:

You build a defined range of devices from a workable, multi-level BOM
You're running a single facility
Standard inspection, pass or fail grading and quarantine cover your quality needs
You want real manufacturing and quality functionality at a cost and timeline built for a smaller operation

Choose Supply Chain Management if:

You're managing production across several sites or legal entities
Engineering changes happen often enough that version control is a daily concern
Formal CAPA and statistical sampling need to run as standard practice every time
Your BOM structure includes configurable products or complex change control

Aspects/Parameters	Business Central	Supply Chain Management
Manufacturing style	Discrete manufacturing (Premium licence)	Discrete manufacturing built for larger operations
Lot and serial tracking	Native	Native, with multi-attribute tracking
Quality management	Native inspection checkpoints and quarantine	Quality orders, non-conformance management, CAPA, statistical sampling
BOM and engineering complexity	Multi-level BOMs, single revision path	Configurable products, complex change control
Organisational scale	One facility, one legal entity	Multiple entities, sites and currencies
Starting licence (UK)	Premium: £84.60/user/month	Standard: approximately £165/user/month

Design control is where Dynamics 365 hands off to something else. Manufacturers with heavy design history file obligations pair it with a dedicated electronic quality management system for design controls and validated electronic signatures, keeping Dynamics 365 as the home for production, inventory and the device history record while the eQMS owns the design record itself. If that split applies to you, expect us to raise it early, well before it becomes a mid-project surprise.

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Fit assessment for the best ERP for medical device manufacturing covering BOM, quality, sites and regulations

What Is the Best ERP for Medical Device Manufacturing?

It comes down to whichever platform matches how you actually build. A single-site contract manufacturer and a multi-site producer wrestling with constant engineering change are dealing with entirely different problems, and the table above shows where those two situations pull apart.

Every enquiry starts with a short conversation covering four things: your BOM, the state of your quality processes, your site footprint, and the rules you need to answer to. That's what decides which platform we point you toward.

Book Your Free Fit Assessment

How Dynamics Square Implement: Step by Step

Dynamics Square delivers every medical device build using Microsoft's Success by Design methodology, five stages that keep validation planning woven into the project from the very outset.

Discover

We spend time on your shop floor understanding your BOM, your routings and how close your quality processes already sit to MHRA expectations

Initiate

Platform choice, scope and project governance get agreed before configuration begins

Implement

The system takes shape while validation documentation is written alongside it

Prepare

Hands-on testing against scenarios pulled from your own production line, training for the people who'll use the system daily, and a cutover date chosen around your manufacturing calendar

Operate

We remain on hand through your first post-launch audits, whatever supplier changes come up, and the fine-tuning that naturally follows

Dynamics 365 Pricing for Medical Device Manufacturers

The numbers below come from Microsoft's current UK price list for 2026, shown in GBP and excluding VAT. What you actually pay depends on user count, any ISV work for design control or eQMS integration, and how the implementation is scoped.

Business Central

Essentials

from £61.50/user/month

Core financials, sales, purchasing and inventory.

Premium

from £84.60/user/month

Adds production orders, BOMs, routings, MRP, MPS and native Quality Management.

Team Members

from £6.20/user/month

Read, approve and light self-service access.

Supply Chain Management

Standard

from £161.50/user/month

Full discrete manufacturing, advanced quality management and warehouse management.

Premium

from £230.70/user/month

Adds advanced analytics and financial planning.

Licence fees are only one part of the bill. Add implementation, and a single-site Business Central project generally lands somewhere in the tens of thousands of pounds. A Supply Chain Management build spanning multiple sites, with validation and eQMS integration folded in, climbs considerably higher, often into six figures.

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Case Studies

Surgical instrument manufacturer upgraded from Dynamics NAV 2013 R2 to Business Central

Surgical Instrument Manufacturer: NAV to Business Central Upgrade

Supplying anaesthesia, surgery, general medical and podiatry products across the UK, this manufacturer was stuck on an ageing, on-premises Dynamics NAV 2013 R2 system with a support partner that was falling short on response times.

We upgraded them to Dynamics 365 Business Central Online, added document management integration, and ran onsite user training throughout the transition.

The result: a cloud-based, Azure-backed system built to support doubled production capacity and revenue growth.

Read the Full Case Study

Orthopaedic implant manufacturer replaced spreadsheets with Business Central

Orthopaedic Implant Manufacturer: Replaced Spreadsheets with Real-Time Visibility

A UK manufacturer of joint replacement, trauma, spine and sports medicine implants was running core operations through spreadsheets, leaving warehouse teams struggling to locate stock and finance struggling to reconcile the bank each month.

We implemented Business Central with WMS Mobile for warehouse operations and a Yavr.io integration for real-time bank reconciliation.

The result: 80% more inventory visibility and a system built to support MHRA compliance requirements.

Read the Full Case Study

UK medical device manufacturers working with Dynamics Square

Why UK Medical Device Manufacturers Work with Us

Every project starts with the regulatory reality already factored in. Tracing a batch, keeping a build record, holding stock for a quality check, these shape the build from the outset, baked in from the earliest planning stage.

We recommend platforms honestly. If Business Central covers everything your operation needs, that's what we say, even when Supply Chain Management is the bigger deal for us.

Our consultants hold current certifications across both platforms, so the comparison you get is grounded in genuine expertise on both sides.

Go-live is where a lot of the real work actually starts. Audits, engineering changes and the process tweaks that follow all sit inside our ongoing support, right alongside your quality system as it keeps evolving.

A device that ends up inside or on a patient carries a weight of responsibility most software vendors never really reckon with. For us, that's the baseline every medical device engagement starts from.

Speak to a Medical Device ERP Specialist

Frequently Asked Questions

Yes, across a wide range of scale, provided the platform matches how complex your build actually is. Business Central handles single-site and contract manufacturers well; larger, multi-site operations generally need Supply Chain Management's deeper capability.

It comes down to your operation's complexity above all else. Dynamics 365 Business Central suits a single facility with a workable BOM. Dynamics 365 Supply Chain Management suits multiple sites, frequent engineering changes, or quality processes that need CAPA and statistical sampling as standard.

Yes, every lot or serial number gets tagged at the point of receipt or production, and that tag travels with the stock through every step that follows, right through to the finished device that shipped.

Yes, Business Central's Quality Management module covers inspection setup, pass or fail grading and quarantine natively. For larger quality operations, Supply Chain Management adds formal non-conformance investigation, CAPA and statistical sampling on top of that.

Yes, as production happens, inspection results and disposition decisions build up automatically against each unit or batch, giving you a build history that's ready whenever it needs reviewing.

Dynamics 365 ERP for Medical Device Manufacturing

At a Glance