MEDICAL DEVICE & IVD REGULATORY
MAGNETOSPHERE
Strategy - Methodology - Compliance
Regulatory strategy and market access for medical devices and IVDs.
Most consultants tell you what the regulation says. We make the regulation work for you — the strategy that gets your product to market and keeps it there, methodologies refined across products and jurisdictions, the standards most others won’t touch, the thinking they won’t have, and compliance built to hold up any time it’s questioned.
Compliance is the outcome, not the starting point.
Seven Field Lines
Seven disciplines. No single line holds the field — all of them do.
Regulatory
You’ve built a good product. Now you’re staring at eight jurisdictions, each with its own rules, its own timeline, and its own way of saying no. Miss one and the whole launch slips.
EU MDR and IVDR, UK MDR 2002, Swiss MedDO, FDA, Health Canada, TGA, PMDA, SFDA. We know how they interact, where they conflict, and which order to take them in. The route to market is never one submission. It’s the strategy that ties them together.
Quality
Your last audit passed, but your system is slowing you down. Every change needs a form. Every form needs a meeting. The QMS built to keep you compliant is now the reason nothing ships on time.
A quality system should keep you in flight, not ground you for inspection. We design management systems that are lean enough to move with you, robust enough to hold under scrutiny, and intelligent enough to know the difference between a requirement and a habit.
Risk
You’ve got a risk file. It’s hundreds of pages, it passed the audit, and nobody has opened it since. Meanwhile the decisions that actually carry risk — the design trade-off, the labelling change, the new supplier — are being made without ever touching it.
ISO 14971 is a way of thinking, not a spreadsheet. We show you how to use risk, not just how to present it at an audit. How to work with it, not how to spend hours documenting it. Risk is the nerve centre of your organisation. When it works, it connects every field line. When it doesn’t, nothing else holds.
Clinical
You claim your device works. The regulator wants proof — not a stack of papers that mention similar products, but evidence that yours does what you say, for the people you say it helps.
Clinical evaluation isn’t a literature review stapled to a submission. Benefit and risk are two sides of the same coin, and clinical evidence is where you prove the balance. We build clinical strategies that serve the product from first concept through post-market, because the evidence you gather today is the argument you make tomorrow.
Post-Market
Your device is on the market. The data is coming in — complaints, returns, the odd field report — and it’s sitting in a folder nobody turns into a decision. Then a trend you should have caught six months ago becomes a serious incident.
The market doesn’t end at CE marking. It’s where your benefit-risk balance meets reality. Most consultancies treat post-market surveillance as a data-collection chore. We don’t. We’ve developed our own methodology for how benefit and risk should be monitored once a device is in the field — one that treats the benefit-risk relationship as the living thing it is, not a number in a spreadsheet. It connects directly to your risk file and your clinical evidence, so what the field tells you changes what you do next.
Safety and EMC
Your product is sitting in a test house. The clock is running, the launch date is looming, and nobody can tell you in plain terms why it hasn’t passed or what it needs to.
These are the standards most consultancies won’t touch. IEC 60601 for electromedical equipment, IEC 61010 for laboratory devices, and the full weight of electromagnetic compatibility. Add the electrical safety marks that sit outside the medical world entirely — C/NRTL, PSE — and the radio requirements that come with anything wireless.
We don’t farm these out to a test house and hope. We live and breathe these standards. That means we can tell you what a clause actually requires before you’re standing in a lab watching a deadline slip.
Software
Your device runs on code, and code is where the regulators are looking hardest. IEC 62304 for the lifecycle. SaMD and cloud-delivered SaaS SaMD classification, when the software *is* the device. AI and machine learning, where the rules are still being written. And the cybersecurity obligations that now sit on top of it all.
Software fails differently from hardware. It doesn’t wear out, it doesn’t fatigue — it does exactly what it was written to do, including the parts nobody meant to write. We treat software as its own discipline, because a bug in a risk control is not a manufacturing defect. It’s a design decision waiting to be found.
Seven Field Lines
Seven Lines, One Field
The field lines that run through medical device and IVD regulation.
No single line holds the field — all of them do.
Regulatory
You’ve built a good product. Now you’re staring at eight jurisdictions, each with its own rules, its own timeline, and its own way of saying no. Miss one and the whole launch slips.
EU MDR and IVDR, UK MDR 2002, Swiss MedDO, FDA, Health Canada, TGA, PMDA, SFDA. We know how they interact, where they conflict, and which order to take them in. The route to market is never one submission. It’s the strategy that ties them together.
Quality
Your last audit passed, but your system is slowing you down. Every change needs a form. Every form needs a meeting. The QMS built to keep you compliant is now the reason nothing ships on time.
A quality system should keep you in flight, not ground you for inspection. We design management systems that are lean enough to move with you, robust enough to hold under scrutiny, and intelligent enough to know the difference between a requirement and a habit.
Risk
You’ve got a risk file. It’s hundreds of pages, it passed the audit, and nobody has opened it since. Meanwhile the decisions that actually carry risk — the design trade-off, the labelling change, the new supplier — are being made without ever touching it.
ISO 14971 is a way of thinking, not a spreadsheet. We show you how to use risk, not just how to present it at an audit. How to work with it, not how to spend hours documenting it. Risk is the nerve centre of your organisation. When it works, it connects every field line. When it doesn’t, nothing else holds.
Clinical
You claim your device works. The regulator wants proof — not a stack of papers that mention similar products, but evidence that yours does what you say, for the people you say it helps.
Clinical evaluation isn’t a literature review stapled to a submission. Benefit and risk are two sides of the same coin, and clinical evidence is where you prove the balance. We build clinical strategies that serve the product from first concept through post-market, because the evidence you gather today is the argument you make tomorrow.
Post-Market
Your device is on the market. The data is coming in — complaints, returns, the odd field report — and it’s sitting in a folder nobody turns into a decision. Then a trend you should have caught six months ago becomes a serious incident.
The market doesn’t end at CE marking. It’s where your benefit-risk balance meets reality. Most consultancies treat post-market surveillance as a data-collection chore. We don’t. We’ve developed our own methodology for how benefit and risk should be monitored once a device is in the field — one that treats the benefit-risk relationship as the living thing it is, not a number in a spreadsheet. It connects directly to your risk file and your clinical evidence, so what the field tells you changes what you do next.
Safety and EMC
Your device is on the market. The data is coming in — complaints, returns, the odd field report — and it’s sitting in a folder nobody turns into a decision. Then a trend you should have caught six months ago becomes a serious incident.
The market doesn’t end at CE marking. It’s where your benefit-risk balance meets reality. Most consultancies treat post-market surveillance as a data-collection chore. We don’t. We’ve developed our own methodology for how benefit and risk should be monitored once a device is in the field — one that treats the benefit-risk relationship as the living thing it is, not a number in a spreadsheet. It connects directly to your risk file and your clinical evidence, so what the field tells you changes what you do next.
Software
Your device runs on code, and code is where the regulators are looking hardest. IEC 62304 for the lifecycle. SaMD and cloud-delivered SaaS SaMD classification, when the software *is* the device. AI and machine learning, where the rules are still being written. And the cybersecurity obligations that now sit on top of it all.
Software fails differently from hardware. It doesn’t wear out, it doesn’t fatigue — it does exactly what it was written to do, including the parts nobody meant to write. We treat software as its own discipline, because a bug in a risk control is not a manufacturing defect. It’s a design decision waiting to be found.
SEVEN PILLARS OF REGULATION
Getting your product to market takes more than one regulation
Between your finished product and your customer, there are gates you didn’t know existed.
The MDR or IVDR are just one framework. Your product lives inside many. So does your quality management system, and so does your regulatory strategy. They shouldn’t just live inside these frameworks. They should guide you through them.
Most consultancies stop at the medical regulation. We think about every gate between your product and your customer.
01
Environmental and Toxicity
Does your product contain chemicals that are harmful to your user or the environment? REACH, RoHS, California Prop 65, CLP
02
Environmental Waste
Have you designed disposal and decommissioning into the product? WEEE, Packaging Directive, Battery Regulation
03
Radio and Wireless
Does your product use wireless communications securely and compliantly? RED, FCC, IC, Bluetooth, Wi-Fi, cellular
04
Biosecurity and Agriculture
Does your product contain animal or plant-derived materials? APHIS, Biosecurity Act, CFIA
05
Cybersecurity
How safe is your customer's data in your product's hands? Cyber Resilience Act, GDPR for connected devices
06
Transport
Does your product contain lithium batteries? Can it fly safely? Lithium battery transport, dangerous goods, IATA
07
Low Voltage and Electrical Safety
LVD, C/NRTL marks, PSE
Why Magnetosphere
A field that cannot be seen, yet without which nothing survives.
Most regulatory consultancies sell process. They audit your QMS, file your submissions, and move on. The paperwork may be correct. A tick. The thinking behind it serves their risk, not yours. A system that keeps you compliant but kills your ability to respond to a new market, a new user need, or a new product iteration has protected the auditor, not the business.
Magnetosphere exists because compliance without judgement is a cage. An organisation may have a certificate, but if it cannot survive a change in regulation or respond to a shift in market, a new user need, or a question it wasn’t expecting, the certificate is just decoration. Your products need to ship. Not next quarter, not after another review cycle, not after someone who hasn’t read the regulation properly says no because saying no is easier than thinking.
We get under the skin of regulation. Not just what it says, but where it applies, where it doesn’t, and where its limitations are being mistaken for its requirements. When the regulatory environment shifts, our clients don’t scramble. They already understand the boundary between what the regulation demands and what it was never intended to reach. They are already onto the next challenge, and succeeding.
Featured Publications
Original Research & Analysis
Placed on the Market: The Constitutive Moment
When exactly is a device placed on the market? The constitutive test, and why it decides everything downstream.
Mergers and Acquisitions: The Conformity That Dies in the Deal
How regulatory conformity quietly collapses during mergers and acquisitions, and how to keep it intact.
Environmental Waste: The Regulations That Won't Stop, They'll Fine You
WEEE, RoHS, REACH and packaging waste as design obligations, not afterthoughts, and the penalties for forgetting.
Under the Magnetosphere
A magnetosphere is the invisible field generated by Earth’s core. It deflects the solar wind — the constant, high-energy bombardment that would strip the atmosphere bare. Without it, life on Earth would be impossible.
Regulations are also a wind of high-energy particles — relentless and constantly shifting. Without the right field around your organisation, they will strip it bare too. The magnetosphere is that field. Magnetosphere Ltd is your protection.
Aurora photograph: Lightscape / Unsplash
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Whether you are navigating a specific regulatory challenge or seeking strategic guidance, we welcome the opportunity to discuss how we can help.
