Market Access

Q: What Does Market Access Mean for Medical Devices?

Market Access is about ensuring that a medical device can be launched and continue to be sold in selected markets in accordance with applicable regulatory requirements. This includes, among other things, regulatory strategy, submissions, engagement with regulatory authorities, and ongoing compliance throughout the product’s lifecycle.

Q: How can market access efforts help shorten time-to-market?

A clear strategy, the right priorities, and high-quality applications reduce the risk of requests for additional information and delays. We take a structured, risk-based approach to ensure predictability in the process and efficient management of interactions with regulatory authorities.

Q: In which markets and regulatory frameworks can you provide support through Market Access?

We have experience with market access in several global markets, including the EU, the U.S., China, Japan, Brazil, Canada, Australia, and the Middle East. Our work includes, among other things, MDR, IVDR, FDA processes, NMPA, PMDA, and other national regulations depending on the market and product.

Q: Can you help with both strategy and day-to-day operations?

Yes, we provide both strategic and operational support. This may involve developing an overall market access strategy, prioritizing markets, and selecting a regulatory pathway, as well as hands-on work with documentation, submissions, regulatory matters, and follow-up.

Q: How do you handle changes, innovations, and after-sales service?

Market Access doesn’t end with approval. We also provide support with registration follow-up, renewals, change control, and impact assessments across multiple markets. This ensures ongoing compliance and reduces the risk of interruptions in market access.

Q: Can you support organizations that lack internal resources in the area of market access?

Absolutely. Many organizations lack the ability to build up full in-house expertise for all markets. We can step in as an extension of their regulatory team and take responsibility for all or part of the market access work, tailored to the organization’s needs and level of maturity.

Q: What sets you apart from other players in the market access sector?

What sets us apart is our combination of global regulatory experience and a practical, business-oriented approach. We focus on solutions that work in practice and support both compliance and business objectives.

Q: How do we know what level of support we need in Market Access?

Needs vary depending on the product, market, internal resources, and timeline. We’re happy to help conduct an initial review and identify the right level of support, whether it’s for a specific project, a new market, or a long-term partnership. Please feel free to contact us, and we’ll tell you more.

A Structured and Effective Path to the Global Market

Securing and maintaining market access involves navigating complex regulatory requirements, varying local expectations, and lengthy review processes. We support organizations throughout the entire registration process with structure, strategy, and operational support that reduce risks and shorten lead times. The goal is a smoother path to market and a sustainable foundation for global growth.

Challenges

Common challenges

Complex regulatory frameworks and increasing demands in several markets

Market access is becoming increasingly demanding as regulations evolve and harmonization across markets decreases. Organizations face challenges related to resources, documentation, and coordination. This often results in delayed launches, increased costs, and higher regulatory risk.

Changing regulations and guidelines across regions

Country-specific requirements and the need for local representation

Extensive and complex technical, clinical, and QMS documentation

Limited internal resources for parallel registrations

Long review periods and unpredictable questions from government agencies

Coordination Across Markets and Aftermarket Requirements

We Offer

Business-Oriented Market Access

From Strategy to Lifecycle Management

We work closely with the organization to develop a clear, risk-based market access strategy tailored to the product, market, and business objectives. With extensive experience in global registrations, we ensure high-quality submissions and effective communication with regulatory authorities. Throughout the product’s entire lifecycle—from market prioritization and regulatory pathway selection to approvals, renewals, and change management—we contribute to control, transparency, and ongoing compliance without placing an unnecessary burden on internal teams.

Marketing Strategy and Prioritization

Support for market sequencing and risk-based prioritization to optimize launch sequencing and resource utilization.

Regulatory Pathways and Application Strategy

Selection of regulatory pathways by product and region, including the EU MDR, IVDR, FDA, and other global markets.

Dossier preparation and gap analysis

Hands-on support in the development, review, and completion of technical and clinical documentation to ensure it meets the standards required for submission.

Submission and Dialogue with Regulatory Authorities

Coordination of submissions, formatting, and quality control, as well as prompt and structured handling of questions and issues.

Upgrades, Modifications, and Aftermarket Parts

Support for registration follow-up, renewals, change management, and impact assessments across multiple markets.

Value We Create

Shorter time-to-market through a clear strategy and high-quality applications

Reduced regulatory risk through experience and local market knowledge

Relieving the workload of internal teams without losing control

Coordinated Management of Multiple Markets and Regulatory Frameworks

Predictability in registration processes and dialogue with government agencies

Support throughout the product's entire life cycle, from planning to after-sales service

A global perspective combined with operational implementation

Customer cases

Here's How We Overcame Past Challenges

Global regulatory compliance that drives market access

Problem: A global launch involves complex regulatory frameworks and extensive communication with government agencies, suppliers, and Notified Bodies. This created a resource-intensive process that risked slowing down access to new markets.

Solution: As a Compliance Partner, we took full responsibility for regulatory coordination and communication, tailored to the client’s needs. The work included market requirements, registrations, CE marking, and support during the change of Notified Body.

Results: Approved product registrations worldwide and a more effective dialogue with all stakeholders enabled faster time to market. The client also gained a stable, long-term compliance solution that strengthens both growth and competitiveness.