We offer you a comprehensive Authorised Representative Service that supports you with MDR Compliance, IVDR Compliance, and AI Act Compliance to gain faster access to the market.
We ensure compliance and serve as your local point of contact, offering thorough documentation review and facilitating Post Market Feedback processes as necessary.
Qualified and experienced team of PRRCs (Person Responsible for Regulatory Compliance) with in-depth regulatory knowledge of various medical devices, including software, active and non-active hardware, and AI systems.
We can assist you in meeting detailed regulatory requirements and standards, supporting both hardware and software medical devices, including those incorporating Artificial Intelligence or devices that are stand-alone Artificial Intelligence Systems.
A leading European Authorised Representative, who assists non-European Medical Device/In-Vitro Diagnostics Manufacturers and AI system providers in complying with European legal requirements.
It is mandatory to have an officially designated PRRC for medical devices and IVD to sell your products in the EU market.
Confidently place your devices on the EU market by partnering with an experienced Authorised Representative.
Experts with deep knowledge of EU compliance frameworks ensure swift regulatory approval for your devices across EU territories.
Our efficient and streamlined approach to compliance helps minimise time-to-market and ensures a smooth regulatory approval process.
We understand the contents of the Artificial Intelligence (AI) Regulation and can support you to demonstrate compliance with the regulation, both stand-alone and when embedded in a Medical Device or IVD.
You can trust us to handle all aspects of your medical device and IVDR compliance with professionalism and integrity.
Dedicated in-house regulatory strategists and local affiliates who assist with preparing, registering, and maintaining regulatory data in EUDAMED.
Our expert team of PRRC for medical and IVD devices ensures organisational compliance with regulations and verifies device conformity according to QMS standards.
Assistance with ISO 13485:2016 certification, gap analyses of source documents, internal mock audit support, and help with remediation plans.
A knowledgeable team that stays updated on the latest regulatory changes, ensuring compliance with evolving requirements.
Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
Chief Advisor
An independent seasoned strategic advisor, a visionary with strong senior leadership experience, focusing on Medical Device compliance globally.
Co-Founder
Agile entrepreneur and venture builder, skilled in empowering distributed teams to foster innovation. Passionate about enabling investors to achieve impact + ROI.
Regulatory Expert
Experienced regulatory affairs consultant in the healthcare industry, specializing in quality systems for medical devices. Authored numerous guidelines and standards for medical technology quality and risk management.
QA & RA Consultant
A digital health expert with over 8 years of experience in regulatory and product management, driving innovative medical software to market.
QA & RA Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory knowledge & AI innovation to deliver compliant medical software solutions.
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and guiding clients through regulatory approval.
Independent QA/RA Consultant & Security Specialist
An SaMD expert with 15+ years of experience specializing in MDR, IVDR, and FDA compliance with a focus on cybersecurity and documentation.
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to ensuring the optimal performance of our online presence.
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns and & Customer Experience Management (CX).
Content Lead
An experienced content specialist crafting compelling, high-quality content across various platforms with meticulous attention to detail.
Explore our blog posts on MDR, IVDR, and AI Act compliance to stay ahead of regulatory changes.
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
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