Medical Device and IVD

MD SW

IVDR MDR ISO 13485 Medical Device and IVD

IVDR – In Vitro Diagnostic Regulation

The EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) introduces stricter requirements for in vitro diagnostic devices on the EU market. The regulation focuses on safety, clinical performance, and traceability to protect patients and ensure the reliability of diagnostic tools.

Our team supports you in navigating the complexities of IVDR by providing:

Assistance with classification of devices according to the new risk-based system.
Guidance in creating and updating technical documentation and performance evaluation reports.
Implementation of robust systems for post-market surveillance and vigilance to maintain compliance.
Support in managing notified body assessments and ensuring alignment with IVDR timelines.

Whether you are transitioning from IVDD to IVDR or launching a new diagnostic device, we offer tailored solutions to streamline your regulatory journey.

Stay ahead of IVDR requirements – contact us to ensure your in vitro diagnostic device complies with the latest EU regulations.

MDR – Medical Device Regulation

The EU Medical Device Regulation (MDR, EU 2017/745) has set new standards for the regulatory requirements of medical devices on the EU market. The regulation imposes strict requirements on safety, traceability, and clinical evidence to ensure products are safe and effective.

We assist you with:

Ensuring your documentation, including the technical file and clinical evaluation, meets MDR requirements.
Preparing for and managing notified body reviews.
Implementing efficient systems for post-market surveillance and risk management in line with MDR guidelines.

With experience ranging from small companies to large multinational organizations, we can guide you through every step of MDR compliance, from strategy to implementation.

Need assistance with MDR? Contact us today to ensure your product remains competitive and compliant on the EU market.

ISO 13485 – Quality Management Systems for Medical Devices

ISO 13485 is the globally recognized standard for quality management systems used in the development, manufacturing, and distribution of medical devices. This standard ensures companies have robust processes in place to meet both customer and regulatory requirements.

Our expertise in ISO 13485 can help you:

Develop and implement a compliant quality management system.
Prepare your organization for certification and regular audits.
Identify and minimize risks in your processes through continuous improvement.

Whether you’re a start-up implementing ISO 13485 for the first time or an established company optimizing existing systems, we provide the support you need.

Learn more about our ISO 13485 services and contact us to elevate your quality management system.

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.

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.