Regulatory services

Regulatory & compliance support

Biofortuna, a strategic outsource partner to the diagnostics industry, can help you with our regulatory services offering. Providing full-service regulatory and compliance support will afford customers a more 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

“Our new Regulatory services offer helps assist our customers in the development of their products, minimizing risk, and maintaining compliance,” said Ian Blackburne, Quality Manger Biofortuna.

Do you have a project that we can help with? Contact us now to arrange a meeting...