You have the idea. You have the market. You have the ambition. What you need now is the backbone to move forward without hitting the pitfalls that stop most products before they start. A regulatory strategy is not a bureaucratic exercise, it is the document that defines your product, protects your investment, and tells every regulator, partner, and investor exactly what you are building and why it is compliant.
Under EU MDR and IVDR, a regulatory strategy is an explicit requirement, not optional. And if you are targeting any additional market the US, UK, Canada, Australia, Japan having this foundation in place from day one saves months of rework and cost. The most common reason medical device and life science companies stall, overspend, or fail to reach market is not a bad product. it is a missing or misaligned regulatory strategy.
Defining your intended purpose, classification, and route to market early is the single highest-return investment you will make in your product's lifecycle.
Credibility Metrics
Companies Audited
Internal audits conducted across more than 85 organizations.
Auditing Hours
Extensive hands-on auditing experience across multiple standards.
Years Unified Team Experience
Proven expertise in ISO management system audits.
Why you Need a Regulatory Strategy?
Required under MDR & IVDR. Essential for every market you target.
- Mandatory under EU MDR & IVDR Article 10 of MDR requires manufacturers to have a defined regulatory strategy as part of their technical documentation. No
Strategy no CE mark. - Defines your product before anything else. Classification, intended purpose, and intended users must be locked before design, clinical, or quality work begins
Changes later are expensive. - Unlocks investor confidence. Investors and partners want to see a structured path to market. A regulatory strategy package shows you have done the groundwork; it is a credibility signal.
- Good to have for every target market, whether FDA, MHRA, Health Canada, or TGA, your EU regulatory strategy is the foundation for all other market strategies
built on.
What do you Receive?
Four fundamental deliverables
01) Intended Purpose Document
Defines precisely what your product does, who it is for, and how it is used. This is the single most important document in your regulatory file, every downstream decision about classification, clinical evidence, and labelling flows from this. Getting it right at the start prevents redefining your product mid-development, which is one of the costliest mistakes a company can make.
MANDATORY - ALL PRODUCT TYPES
02) Device Description Document
A structured, regulatory-grade description of your product, its physical characteristics, components, materials, software, accessories, and
variants. This document is what regulators, notified bodies, and auditors use to understand your product. Whether you make a medical device, a food
supplement, an industrial sensor, a connected health platform, or a cosmetic, this document draws the boundary of what you are responsible for.
You will get a template; it’s a prerequisite to start the work.
MANDATORY - ALL PRODUCT TYPES
03) Classification Document
Determines the regulatory class of your product and what that means for your route to market. Classification rules apply across every regulated
industry: medical devices (MDR Class I to III), in vitro diagnostics (IVDR Class A–D), food & supplements, cosmetics, pharmaceuticals, software as a medical device (SaMD), industrial & machinery products, and chemical products. Your class determines your timeline, your clinical burden, and your
cost, knowing it early is non-negotiable.
MANDATORY - DETERMINES YOURE ENTIRE PATHWAY
04) Regulatory Strategy Document
The master document is a clear, structured plan for how your product reaches the market. It maps your regulatory pathway, identifies the standards and guidelines that apply, outlines your evidence plan, sets out your timeline and key milestones, and defines what you need to do next. This is the document that gives your team, your investors, and your notified body a single source of truth for your regulatory journey. Required under MDR/ IVDR Article 10 and best practice under every other framework.
MANDATORY UNDER MDR - BEST PRACTICE GLOBALLY
PRICING
Transparent, Scope-Based Pricing
A fixed base package covering EU requirements, with clear add-on pricing for each additional market.
Base Package — EU Market— 85,000 – 120,000 NOK (excl. VAT)
(Depending on the product classification and overall complexity)
All four deliverables (Intended Purpose, Device Description, Classification Report, Regulatory Strategy Document) are scoped for EU MDR, IVDR, or applicable EU framework. Delivered as a complete, submission-ready document package.
Base Package Includes:
- Intended Purpose Document
- Device Description Document
- Classification Report
- Regulatory Strategy Document
- EU MDR / IVDR alignment
- 1 review & revision round
ADDITIONAL MARKETS : +12000 KR PER MARKET
| Country | Regulatory Info | Price |
|---|---|---|
| 🇺🇸 United States | FDA 510(k) / De Novo / PMA | +12 000 kr |
| 🇬🇧 United Kingdom | MHRA UKCA | +12 000 kr |
| 🇨🇦 Canada | Health Canada – MDR | +12 000 kr |
| 🇦🇺 Australia | TGA – Therapeutic Goods | +12 000 kr |
| 🇯🇵 Japan | PMDA – SAKIGAKE | +12 000 kr |
| 🇨🇳 China | NMPA registration | +12 000 kr |
Pricing is fixed and scope-based. No hidden fees. If your product requires additional scoping after the initial assessment, we will inform you before any work begins. All
deliverables are yours to keep fully editable, submission-ready documents.