Regulatory strategy and planning for medical devices

Regulatory strategy & planning

A well-defined regulatory strategy is essential for bringing Medtech products to market efficiently while ensuring compliance with global regulations. Poor planning can lead to delays, unexpected regulatory hurdles, and costly redesigns.

Our consultants provide strategic guidance to help you navigate the complex regulatory landscape, ensuring a smooth path to approval in the EU, UK, US, and other key markets.

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Strategic regulatory planning for Medtech market success

The Medtech industry is subject to evolving regulatory requirements that vary across regions. Without a clear regulatory strategy, companies risk misalignment with market entry requirements, delays in approvals, and increased costs due to unforeseen compliance gaps.

Our consultants help you:

  • Define a regulatory roadmap that aligns with your business objectives and target markets.
  • Navigate the most approval pathways for CE marking, UKCA certification, FDA clearance/approval, and other global markets.
  • Anticipate regulatory challenges and integrate compliance requirements early in product development.
  • Ensure smooth interactions with Notified Bodies, Competent Authorities, and the FDA by preparing structured submissions.

Why use our support with regulatory strategy?

Navigating regulatory requirements requires deep expertise and forward-thinking planning. Our consultancy services include:

  • Regulatory Roadmap Development – Defining a step-by-step plan for achieving market approval.
  • EU MDR/IVDR & UKCA Compliance Strategy – Ensuring conformity assessment pathways align with product classification and intended use.
  • FDA Submission Planning – Determining the best regulatory pathway (510(k), De Novo, PMA) for US market entry.
  • Global Market Expansion Support – Helping you comply with regulatory frameworks in multiple jurisdictions, such as Australia, Middle East, Brazil, and Japan.
  • Pre-Submission & Consultation Support – Engaging with regulators and Notified Bodies early to clarify requirements and avoid delays.
  • Combination Product & Digital Health Regulatory Strategy – Advising on unique compliance considerations for software as a medical device (SaMD) and drug-device combination products.
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.