Regulatory Strategy Services
Experienced Regulatory Leadership for Medical Device & IVD Companies.
Regulatory strategy provides a clear framework for guiding a medical device or IVD from concept through market clearance and into post-market activities. A defined strategy establishes development direction, regulatory expectations, and decision-making criteria across regulatory, technical, and business functions.
AJW Technology Consultants provides regulatory strategy development and ongoing regulatory leadership for medical device and IVD companies. Our role extends beyond strategy definition into continued regulatory involvement throughout product development, submission preparation, and post-market phases. Regulatory strategy and regulatory execution are managed under consistent regulatory leadership across the product lifecycle.
What Is Regulatory Strategy?
Regulatory strategy defines the path from concept to market clearance and through post-market compliance. It answers critical questions that determine your timeline, budget, and probability of success:
- What regulatory pathway applies? (510(k), PMA, De Novo, EU MDR, EU IVDR)
- How should your product be classified?
- What claims can you make?
- What data and evidence do regulators expect?
- How should development activities be sequenced?
- What post-market obligations apply?
Regulatory strategy provides clear direction for development teams and informs regulatory, technical, and business decisions throughout the product lifecycle.
How AJW Tech Supports Your Regulatory Strategy
1. Defining Your Regulatory Pathway
We start by understanding your product, intended use, target markets, and business objectives. Then we evaluate applicable regulatory pathways across FDA, EU MDR, EU IVDR, UK, and other global markets.
Pathway determination includes:
- Product classification by jurisdiction
- Intended use and indications for use refinement
- Predicate device identification for 510(k) pathways
- Assessment of novel features requiring additional considerations
- Comparative analysis of pathway options (timeline, cost, probability of success)
The right pathway saves months of development time and prevents dead-end routes.
2. Identifying Data and Evidence Requirements
Once your pathway is clear, we define what data and evidence regulators expect.
This includes clinical data requirements, performance testing protocols, biocompatibility evaluations, software validation documentation, and risk management files.
Understanding evidence requirements upfront prevents reaching the submission stage only to realize you’re missing critical studies, which can delay clearance.
3. Sequencing Development and Submission Activities
Regulatory strategy includes defining what activities are required and when they occur. We sequence development and submission activities so regulatory expectations are addressed in the correct order and carried through into the submission itself.
- Timing of verification and validation activities
- Design control milestone planning tied to regulatory review expectations
- Preparation for pre-submission and scientific advice meetings
- Active submission preparation, content review, and readiness checks
- Authority response planning and management of review timelines
Submission preparation is treated as a continuation of regulatory strategy, with the same regulatory leadership involved through filing and authority interaction. This approach maintains continuity from development planning through submission review and post-submission correspondence.
4. Ongoing Regulatory Leadership Through Development
Regulatory strategy continues throughout development as the product, testing results, and project priorities evolve. We remain engaged as regulatory leadership across development, submission activities, and post-market planning, with continuity from early decisions through authority interaction.
- Regular strategy reviews and adjustments
- Design control and documentation guidance
- Authorities support (pre-submission meetings, responses to questions)
- Submission preparation and review
- Post-market strategy (surveillance, follow-up, design changes)
Who Needs Regulatory Strategy Services?
Startups and founders developing their first regulated product who need experienced guidance navigating FDA, EU MDR, or other regulatory pathways without hiring full-time regulatory staff.
Small to mid-size companies expanding into new markets or developing new product lines who lack sufficient in-house regulatory expertise to manage multiple pathways.
Engineering-led teams who understand product development but need regulatory expertise to translate technical capabilities into compliant documentation and submission strategies.
Companies facing regulatory setbacks who received FDA questions, CE Mark challenges, or submission rejections and need senior regulatory judgment to get back on track.
Global Market Coverage
Our regulatory strategy and submission services cover all major markets:
- United States: FDA pathways (510(k), PMA, De Novo, IND, NDA, ANDA)
- European Union: EU MDR 2017/745, EU IVDR 2017/746 compliance, and Low Voltage Directive
- United Kingdom: UKCA marking, MHRA requirements, and Low Voltage Regulations
- Switzerland: SwissMedic requirements and market access
- Australia and New Zealand: TGA and Medsafe regulatory pathways
- Canada: Health Canada Medical Device License (MDL) and Medical Device Establishment Registration (MDEL)
Why Choose AJW for Regulatory Strategy
AJW Technology Consultants provides senior-level regulatory leadership for medical device and IVD companies seeking clear regulatory direction and consistent execution. Regulatory strategy, development guidance, and submission activities are handled under experienced regulatory oversight with continuity across the product lifecycle.
Our approach combines regulatory judgment, practical pathway definition, and hands-on involvement through development, submission, and post-market activities. This model provides regulatory leadership equivalent to an experienced internal function while remaining flexible and scalable for growing organizations.
Contact us to discuss your regulatory strategy or submission →