MD SW - PharmaRelations AB

Medical Device Software: Expertise That Matters

At PharmaRelations, we specialize in Regulatory and Quality Services for medical device software – stand-alone (SaMD), embedded or an integral part of the final medical device or IVD –ensuring compliance with international standards such as IEC 62304. Our expertise helps you navigate the complex regulatory landscape with a smart, fit-for-purpose approach that accelerates compliance and speeds up your time to market.

Contact us for more information

IEC 62304 Compliance for Medical Device Software

IEC 62304 is the internationally recognized standard for the development and maintenance of medical device software. Compliance with this standard is crucial to ensuring the safety and effectiveness of your software. Our services include:

Software Development Lifecycle Compliance – We help you establish and implement compliant software development processes, including risk management, verification, and validation.
Gap Analysis & Risk Assessment – Our team identifies gaps in your current development processes and provides strategic recommendations to achieve compliance.
Technical Documentation & Audits – We assist in the preparation of comprehensive technical documentation required for regulatory submissions.
Regulatory Submissions & Support – We guide you through the submission process, ensuring compliance with FDA, MDR, IVDR, and other regulatory frameworks.
Post-Market Surveillance & Maintenance – Ensuring ongoing compliance by assisting with software updates, change management, and post-market monitoring.

Expertise in Medical Standards Development

Our commitment to regulatory excellence extends beyond consulting services. We are active members of the Swedish branch of the Technical Committee responsible for developing international standards related to medical equipment, software, and systems. This involvement ensures that we stay at the forefront of regulatory and technological advancements, providing our clients with cutting-edge insights and strategic guidance.

Why Choose Us?

Industry Expertise – Hands-on experience and a successful track record in medical device software development and regulatory compliance.
Global Compliance Knowledge – In-depth understanding of FDA, EU MDR/IVDR, and other global regulatory requirements.
Tailored Solutions – Custom strategies designed to meet the unique needs of your software and organization.

Contact us