About DEMEDs

DEMEDs is a regulatory consulting firm supporting medical device manufacturers in achieving compliance and expanding into international healthcare markets.

We provide specialized expertise in European regulatory frameworks such as the European Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746, while also assisting companies in entering emerging markets including Turkey and Central Asia.

Our team combines regulatory knowledge, clinical evaluation expertise, and international market access strategy to support manufacturers throughout the entire product lifecycle—from regulatory approval to global expansion.

By integrating compliance expertise with market entry strategy, DEMEDs enables manufacturers to bring safe and innovative medical technologies to patients worldwide.

 

Our Mission

Our mission is to support the development, approval, and global availability of safe and innovative medical technologies.
We achieve this by helping manufacturers meet complex regulatory requirements while enabling efficient market access across Europe and emerging healthcare markets.

 

Our Expertise

European Regulatory Compliance
We support manufacturers in achieving and maintaining compliance with European medical device regulations through comprehensive regulatory consulting services.

Our expertise includes:

• EU MDR compliance strategy

• EU IVDR regulatory support

• Clinical Evaluation & Post-Market Clinical Follow-Up (PMCF)

• Technical Documentation preparation

• Risk Management integration (ISO 14971)

• Post-Market Surveillance systems

 

International Market Access

Beyond Europe, DEMEDs assists medical device manufacturers in expanding into new markets by navigating regional regulatory systems and developing effective market entry strategies.
Our services include support for expansion into markets such as:

• Turkey

• Kazakhstan

• Uzbekistan

• Kyrgyzstan

• Tajikistan

We guide manufacturers through registration procedures, regulatory requirements, and distributor coordination to facilitate successful market entry.

Collaboration with Notified Bodies and Regulatory Authorities
DEMEDs supports manufacturers during interactions with European Notified Bodies and regulatory authorities throughout the conformity assessment process.
Our regulatory approach focuses on preparing robust technical documentation, strengthening clinical evidence, and ensuring regulatory readiness for certification reviews.
This structured preparation enables manufacturers to efficiently navigate regulatory assessments and maintain long-term compliance.

 

Our Approach

At DEMEDs, we believe that successful regulatory strategy extends beyond certification.
Our approach combines:

✔ Regulatory compliance expertise


✔ Clinical and scientific evaluation


✔ Strategic market access planning

✔ Long-term lifecycle regulatory support

This integrated perspective allows manufacturers to move from regulatory approval to global market expansion with confidence.