A Source of Quality and Regulatory Innovation
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
- 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.
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