Our Team

Kristi Pillans

Managing Director

Kristi has successfully worked within the medical sector for over 15 years, providing strategic leadership for Quality & Regulatory Affairs as a PRRC (Person Responsible for Regulatory Control) and defining regulatory pathways at Board Level for strategic projects as a Regulatory Affairs Consultant.

Provides leadership, whilst managing technical guidance and training, to cross-functional teams and other RA members including training on procedures, MDR guidance documents, and international regulation.

Implementation and subsequent management of ISO 13485, ISO 14001 & ISO 9001
BSI Lead Auditor Medical Devices ISO 13485
Responsible for meeting regulatory requirements
Companywide integration of QMS software
Support internal and external stakeholders with regulatory guidance, regulatory documents
Responsible for FSCA & FSN incidents
SOPs & policies
Legal compliance
Warehouse stock management systems
Contract negotiation
Notified Body external audits
Draft Regulatory Submissions
Post Market Surveillance

Victoria Bradford

Quality Manager

Victoria’s background is diverse, including, Commercial Litigation, Medical Device Quality & Regulatory Affairs, Private Client & Corporate Banking.

Victoria performs a hybrid role, providing EA support to the Managing Director and a QARA function including:

- Internal medical / environmental auditing
- Contract Management
- Notified Body external audits
- Writing SOPs & policies
- Data analysis for ISO reporting
- Regulatory compliance
- Supplier Management
- QMS Management
- EMS Management
- Explant Management

Adam Prangnell

Quality Affairs Coordinator

Adam’s background is in the legal sector and is adept at reading and interpreting complex legislation and regulations, and using the knowledge gained to successfully challenge decisions made by government departments. Adam was also responsible for delivering training programmes to increase the knowledge and efficiency of related sectors.

Adam now utilises this eye for detail and ability to decipher legal and regulatory requirements for the medical device sector, and is trained in the application of:

Supplier Management & Compliance
QMS Management
EMS Management
Data analysis for ISO reporting
Writing SOPs & policies
Tender submissions
Investigating funding opportunities for new products
Monitoring internal & external regulatory compliance