Regulatory services

Regulatory & compliance support

Our regulatory service provides customers with full compliance support and a comprehensive partnership for the design, development and manufacturing of in-vitro diagnostic (IVD) devices, particularly class 2 and 3 medical devices.

Benefit from our knowledge, having developed over 100 assays on an OEM basis from our state-of-the-art, FDA registered and ISO 13485 certified facility.

Our in-house regulatory experts will work with customers’ project management teams and regulatory departments to develop safe, effective, and compliant products to avoid regulatory issues.

You may be aware of the recent regulatory overhaul of EU Medical device directive (MDD) to Medical device regulations (MDR) and In-Vitro Diagnostics Directive (IVDD) to In-Vitro Diagnostics Regulations (IVDR) which will be effective from May 2020 and May 2022 respectively. As per the new regulations, manufacturers should consider submitting:

  • a Clinical Evaluation Report (CER) along with the CE Technical File
  • a Performance Evaluation Report (PER) along with the technical file for IVD submissions

Minimise the risk of regulatory issues and talk to us today!

The offering is designed to ensure compliance with regulatory requirements and assisting customers in key areas:

Pre and post audit support
Provide safety regulatory information
Design plan development
Document preparation for regulatory submissions
Creation & management of design history files (DHF)
Navigation of regulatory pathways
Documenting & executing protocols / testing for validation

Get in touch to arrange an informal exploratory discussion!

Do you have a project that we can help with? Contact us now to arrange an informal exploratory discussion.
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