Your Trusted
Partner

With decades of expertise in regulatory compliance and quality assurance within life sciences, we are your trusted partner in the medical device, diagnostic, medtech and healthtech industry. MedDev Regulatory (MDR) Consulting, help university spin-offs, start-ups, SMEs, and long-established organisations globally, navigating the ever-evolving regulatory landscape ensuring ongoing compliance.

Whether you need technical file compilation, gap analysis, maintenance, or remediation we can help. As experts in technical file documentation, we help ensure that your documentation meets compliance standards, ensuring the continued safety of your device.

REGULATORY
REQUIREMENTS

The technical file documentation required for medical devices and IVDs is indicated in Annexes II and III of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).

Navigating 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, which can be overwhelming.

TECHNICAL FILE
DOCUMENTATION
ISSUES

As regulatory experts, we have seen recurring issues where technical file documentation does not comply with applicable regulatory requirements, which 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 it is crucial it is kept up to date after the device's launch. Technical files are an important aspect of ensuring regulatory compliance throughout the life cycle of your product. We understand the importance of thorough documentation and will help ensure that your technical files meet all the necessary requirements and are compliant.

MedDev Regulatory (MDR) Consulting has compiled, reviewed, maintained and conducted gap analysis and remediation of technical files for a diverse range of medical devices and IVDs. We are your regulatory technical experts.

Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.