Your Trusted
Partner

REGULATORY AFFAIRS & QUALITY
ASSURANCE EXPERTS

With decades of proven expertise in regulatory compliance and quality assurance, we are your trusted partners. We support organisations across the medical device, medtech, healthtech, biotech, and pharmaceutical industries. From university spin-offs and start-ups to SMEs and global enterprises, we help you navigate the ever-evolving regulatory landscape.

Whether you need technical file compilation, gap assessment, maintenance, or remediation we can help. We help you ensure that your technical files meet compliance standards, ensuring the continued safety of your products.

REGULATORY
REQUIREMENTS

EU MDR 2017/745 and EU IVDR 2017/746

A comprehensive technical file and effective post-market surveillance are critical for achieving and maintaining regulatory compliance in the medical device industry. These essential components not only demonstrate the safety and effectiveness of your devices but are also mandatory for securing market approvals for CE UKCA marking, MDR, and IVDR certification.

The intricacies of regulatory requirements can be challenging, and you will need to be prepared for increased scrutiny of devices due to changes from directive to regulation under EU MDR 2017/745 & IVDR 2017/746.

TECHNICAL FILE
DOCUMENTATION
ISSUES

TECHNICAL FILE COMPLIANCE

If technical file documentation does not comply with applicable regulatory requirements, this can lead to delayed market access, impacting patient health, inhibiting new technology innovation and non-compliance.

A Notified Body can withdraw ISO certification if the technical files supporting your products are not compliant. This would mean that the CE Mark could no longer be applied to product labelling and that your products could no longer be sold in countries where the CE Mark is required.

We Can Help

Technical file documentation is a living document that must meet regulatory standards during development, and after your product launch. They are a vital aspect in maintaining regulatory compliance throughout your product's life cycle, as comprehensive documentation is crucial to ensure your technical files meet all required standards and remain fully compliant.

MedDev Regulatory (MDR) Consulting has compiled, reviewed, maintained and conducted gap assessment and remediation of technical files for a diverse range of life science companies. We are your regulatory technical experts.

Our consultancy services are tailored to meet your needs at competitive and cost-effective rates. Contact us today for a free consultation

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