Pirus Consulting Ltd is an independent consultancy specialising in providing a Regulatory and quality management service to companies with high technology products in Medical Device and Bio/pharmaceutical sector. These can be start-ups as well as medium to large companies

Services:

  • Product definition for high technology Medical Devices (including combination devices) and IVD’s and Medicinal Products (Pharmaceuticals, biopharmaceuticals) 
  • Definition of the regulatory and compliance pathways for new high technology products including those employing software. 
  • Regulatory dossier writing, development and filing for Medical Devices including:
  • Technical Files for CE Marking per Medical Device Directive (and Regulations) and IVD Directive (and Regulations)
  • CE Marking Medical devices and IVD’s  
  • Design History File Development to FDA requirements. 
  • Regulatory filing to FDA requirements including PMA development and submission 
  • 510(k) submissions  
  • Review, writing and compilation of CMC Module 3 and Module 4 for Pharmaceuticals and Biopharmaceuticals for inclusion in CTD submissions. 
  • Design of bespoke Quality Management Systems based on any international (ISO) or National standard or National or International Regulatory Guidance Documents. 
  • Specialist in Software Lifecycle Management standard in Medical Devices (IEC 62304) 
  • Specialist Quality Management Training to ISO13485, GMP, GLP, GCLP and ISO 9001.
  • Pirus consulting provides services for start-ups as well as established companies.

A recent submission to the FDA…. all in a day’s work!

A recent submission to the FDA…. all in a day’s work!


Pirus Consulting collaborates with other consultancy groups with the aim of providing a wider range of regulatory expertise to our joint customers:

 

Pirus Consulting is also a member of:

 

SPIN Committee for Medical Devices