Why Medical Device Manufacturers Trust Us
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Choosing the Right Dynamics 365 for Medical Device Manufacturing
Two Microsoft products cover this industry, and how complicated your production actually is decides the fork in the road, well ahead of your headcount.
Dynamics 365 Business Central
Business Central is a fit for contract device manufacturers and single-facility producers working from a defined, multi-level bill of materials. You get genuine manufacturing and quality depth without paying for capability your operation will never touch.
Explore Business Central
Dynamics 365 Supply Chain Management
Supply Chain Management is built for manufacturers spanning several sites, managing frequent engineering revisions, or running formal non-conformance investigation and statistical sampling as every day, standing practice. Configurable products and layered change control live here.
Explore Supply Chain ManagementA Medical Device Licence never comes bundled with either platform's subscription. Health Canada grants that directly to your device once your quality system proves itself through MDSAP-certified processes. What Dynamics 365 contributes instead is the lot, serial and engineering revision data your team pulls up the second Health Canada asks a question.
Talk to Us About Your Manufacturing ProcessWhat Canadian Medical Device Regulation Requires
Dynamics 365 for medical device manufacturing gets built around exactly these obligations, so here's what Health Canada actually asks of a device manufacturer.
Device classification under the Medical Devices Regulations
Health Canada sorts devices into four classes under the Medical Devices Regulations, SOR/98-282, running from Class I at the lowest risk, things like basic surgical instruments, up to Class IV for the highest-risk devices, such as implantable cardiac technology. Where your product lands on that scale decides almost every other requirement that follows.
Medical Device Licence and Medical Device Establishment Licence
Class II, III and IV devices each need a Medical Device Licence before they reach the Canadian market, with the technical file scaling up in depth as risk class rises. Class I devices skip the MDL, but every manufacturer, importer and distributor still needs a Medical Device Establishment Licence to operate in Canada, regardless of which class they're selling.
MDSAP as the accepted quality system evidence
For Class II through IV, Health Canada wants a current Medical Device Single Audit Program certificate covering ISO 13485 as proof your quality system actually works. Health Canada wants that certificate specifically issued through the MDSAP program, a detail that catches manufacturers coming from other markets more than once.
Mandatory problem reporting
An incident that caused death or serious deterioration in health has to reach Health Canada within 10 calendar days. One with the potential to cause the same outcome if it happens again gets 30 calendar days. A foreign incident already reported to another regulator gets a tighter 48-hour window once that decision to act is made.
Recall obligations
Deciding to recall a device likely to cause injury starts a 24-hour clock to notify Health Canada, and a final recall report is due within 30 calendar days of closing it out. Recall type, from most to least urgent, sets how fast affected customers need to hear from you too.
What Dynamics 365 Does for Medical Device Manufacturers
Strip away the marketing and a medical device ERP has one real job: name the exact lot behind any shipped unit, name who inspected it, and name where it went, without anyone digging through three systems to piece it together. The capabilities below all point back to that job.
Traceability
The moment a component lot lands at goods receipt or a unit rolls off the line, it picks up a tag that follows it through assembly, testing and the loading dock. That's what lot and serial number tracking software is for: type in a unit number and its entire component history comes back, or start from a component and see every device it touched.
Device history records
As a production order moves through the shop floor, the inspection outcomes and disposition calls tied to it get captured without anyone stopping to file paperwork separately. That's device history record software doing its job quietly, so a completed build folder is already sitting there the day someone needs to pull it.
Quality control
Set up an inspection checkpoint, grade the result pass or fail, and send anything that fails to quarantine, all native to Business Central out of the box. Manufacturers running deeper quality programs step up to Supply Chain Management, where medical device quality management software adds structured non-conformance cases, CAPA workflows and statistical sampling plans as a standard part of daily operations.
Bill of materials and engineering control
A multi-level BOM, its routing and its full revision trail all live inside the same record, so bill of materials software for medical devices means an engineering sign-off updates every future build automatically, on its own, while the paper version used to mean chasing down five documents by hand.
Production planning
Demand turns into a realistic schedule through MRP and MPS, weighed against actual shop capacity and what components are sitting on the shelf. Medical device production planning software of this kind keeps a late supplier shipment or a fresh engineering change from quietly blowing up next week's plan.
Inventory control
Bin-level stock accuracy, reorder points tuned to what genuinely moves, and an automatic hold the instant a lot fails inspection. That's medical device inventory management software doing more than counting boxes.
Supplier quality
A vendor's approved status, their incoming inspection results and their corrective action record all sit against the actual components they sent you. Supplier quality management software built this way means one weak supplier never hides behind a clean-looking overall pass rate.
Recall readiness
Should you ever need it, product recall management software built into the same system already holds which units, lots and customers are connected, so the data side of a recall never becomes the bottleneck.
Business Central vs. Supply Chain Management for Medical Devices
You are likely to have a learning from the section above. Here's the technical breakdown to confirm it, or to bring into a conversation with your own IT team.
| Aspects | Business Central | Supply Chain Management |
|---|---|---|
| Best suited to | Contract manufacturers, single-site device makers | Multi-site manufacturers, complex engineering environments |
| Manufacturing style | Discrete manufacturing (Premium licence) | Discrete manufacturing at enterprise scale |
| 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 |
| Organizational scale | One facility, one legal entity | Multiple entities, sites and currencies |
| Starting licence (Canada) | Premium: $149.20 CAD/user/month | Standard: $284.90 CAD/user/month |
Both platforms treat medical device production as discrete manufacturing, a different world from process industries like pharmaceuticals where formula and potency adjustment drive the decision. Here it's BOM complexity, the depth your quality process actually requires, and your site and entity count that separate one platform from the other.
Design control stays outside both platforms as a separate discipline. When a manufacturer's design history file obligations run deep, we typically bring in a dedicated electronic quality management system to own validated electronic signatures and the design record, while Dynamics 365 keeps running production, inventory and the built device history behind it. That division of labour comes up early in discovery, well ahead of the build itself.
Get a Platform RecommendationHow Does Dynamics Square Help You Find the Right Fit
A contract manufacturer running one steady device line and a company juggling engineering changes across three sites are shopping for genuinely different tools, even though both sell into the same regulated market. Pick the wrong one and you feel it twice, first in a project sized for the wrong platform, then in every workaround your team invents afterward to make it behave.
Before we point anyone toward a product, we walk through your bill of materials, where your quality process actually stands today, how many sites you run, and what Health Canada expects from your specific device class. That fact-finding comes before any recommendation, never after one.
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How Dynamics Square Implements
Microsoft's Success by Design framework carries every medical device build we deliver, and it breaks into five stages.
Discover
Our team walks your shop floor to map the BOM, the routings and how far your current quality process sits from what Health Canada expects.
1
2
Initiate
It locks in the platform, scope and who signs off on what before a single screen gets configured.
Implement
It is where configuration and validation documentation move forward side by side, in step with each other.
3
4
Prepare
It puts the system through testing built from your actual production scenarios, trains your people on it, and lines up a cutover date that respects your manufacturing schedule.
Operate
It keeps us involved once you're live, through the first audits, supplier swaps and the small refinements that always follow a launch.
5
Dynamics 365 ERP Pricing for Medical Device Manufacturing
These are Microsoft's published CAD list prices for 2026. What you'll have to pay depends on your user count, any eQMS or design control add-ons, and how big the implementation turns out to be, so treat this as a starting point ahead of a proper quote.
Business Central
Essentials
From $108.50CAD/user/month
The finance, sales, purchasing and inventory basics most operations run on
Premium
From $149.20CAD/user/month
Essentials plus production orders, BOMs, routings, MRP, MPS and native Quality Management
Team Members
From $10.90CAD/user/month
Lightweight access for approvals and self-service tasks
Supply Chain Management
Standard
From $284.90CAD/user/month
Full discrete manufacturing at scale, advanced quality management and warehouse management
Premium
From $407.00CAD/user/month
Standard plus advanced analytics and financial planning capability
The licence fee is the smaller number on most projects. Add a Business Central implementation at one facility and the total generally settles in the mid five figures. Stretch that across several sites on Supply Chain Management, with validation work and eQMS integration folded in, and the budget climbs into six figures fairly quickly.
Get a Custom QuoteWhy Canadian Medical Device Manufacturers Choose Dynamics Square
Lot traceability, engineering revision control and quality holds get scoped into a project from the opening conversation, because retrofitting them after go-live is a much harder job
A Business Central recommendation gets made just as readily as a Supply Chain Management one, with the decision anchored entirely in what your production actually needs, invoice size aside
Both platforms stay current across our consulting team, so the fit assessment you receive comes from people who work in both products regularly and equally
Once you're live, our involvement continues at full strength. Audits, engineering revisions and the tuning that follows a real launch all sit inside ongoing support
Years spent inside Canadian regulated manufacturing means MDSAP audits, bilingual labelling and Health Canada's review process are already familiar territory before your kickoff call
Frequently Asked Questions
It works well for device manufacturers of nearly any size, provided the product chosen matches how the operation actually builds. A contract manufacturer at one facility gets everything needed from Business Central, while a company running several plants with constant engineering churn outgrows it and moves to Supply Chain Management.
Look at how your production actually runs before looking at company size. A single facility working from a defined BOM fits comfortably inside Business Central. Several sites, engineering revisions that never stop, and a quality team that needs CAPA and statistical sampling built in point toward Supply Chain Management instead.
Yes, both platforms assign a lot or serial identifier at receipt or production, and that identifier travels through every downstream step, purchasing, assembly, shipping. One search shows exactly where a specific unit or lot ended up.
It does, natively in Business Central: create an inspection, mark it pass or fail, and quarantine takes care of anything that fails right there in the same screen. Operations that need more, structured non-conformance cases, CAPA and statistical sampling as routine, get that depth by stepping up to Supply Chain Management.
Yes, inspection results and disposition decisions accumulate against each unit or batch automatically as production happens, giving you a documented build history that's ready whenever Health Canada wants to review it.
Build Devices Backed by a System That Proves Its Work
Bring your lot data, quality workflow and build documentation into one system your team can trust every day, especially under real inspection pressure.
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