Navigating Regulatory Support for IVDR and MDR Software

In the rapidly evolving landscape of the life sciences, medical device, and healthcare industries, regulatory compliance plays a pivotal role in ensuring the safety and efficacy of software solutions. For companies seeking regulatory support for their IVDR (In Vitro Diagnostic Regulation) and MDR (Medical Device Regulation) software, Repado emerges as a trusted partner. With over 15 years of dedicated focus in the MDR and IVDR fields, Repado combines innovation with regulatory expertise to provide a competitive edge on the healthcare market.

Repado: Your Medical software Regulatory Affair Expert

Repado is an innovative software development and regulatory affairs company that specializes in the life sciences, medical device, and healthcare sectors. Our core mission is to empower our partners with high-quality, consistent, and tailor-made technology solutions designed to meet their unique needs and help them attain maximum value in a regulated environment.

Regulatory Certification and Quality Management

At Repado, being also a developer of medical software, we understand the critical importance of adhering to stringent quality and regulatory standards. Our internal Quality Management System (QMS) is certified under ISO 13485:2016 and ISO 9001:2015 by respected certification bodies such as TÜV Hellas and TÜV Nord Group. Our primary scope is the "Design & Development of medical software", encompassing both embedded and stand-alone software solutions.

Our software development lifecycle process (SDLC) is meticulously crafted to fully align with all relevant software-related standards and guidelines, including IEC 62304, IEC 82304, IEC 62366, ISO 14971, and more. This commitment to quality and compliance ensures that the software solutions we develop are not only technologically robust but also meet the rigorous regulatory requirements of the industry.

The Repado Advantage: Turning Ideas into Certified Software

Leveraging our extensive regulatory experience, Repado's team of specialists is here to guide you through the complex landscape of IVDR and MDR compliance. We offer a comprehensive suite of services aimed at helping you understand, implement, and conform to regulatory requirements, ultimately transforming your software ideas into certified products.

Whether you're navigating the CE marking process, CE/IVD certification, or FDA compliance, Repado has the expertise and resources to support you at every stage. Our regulatory support services include:

Regulatory Strategy: We assist in formulating a tailored regulatory strategy that aligns with your specific software product and target markets.
Regulatory Documentation: Our experts help prepare and compile the necessary documentation, such as Technical Files and Design Dossiers, essential for regulatory submissions.
Compliance Testing: We facilitate and oversee the testing and validation processes required to meet regulatory standards.
Audit Readiness: Prepare for regulatory audits with confidence, thanks to our audit readiness services and mock audits.

With Repado by your side, you can turn your software vision into a certified reality, ensuring that your product meets the highest standards of safety and effectiveness while staying ahead in the competitive healthcare market.

Are you ready to embark on a regulatory-compliant journey with us?