Welcome
Regulatory Affairs and Quality Assurance IVD Consultancy
Pragmatic regulatory and quality strategies to support your IVD business
FKG Consultancy
Compliance Delivered
FKG Consultancy specializes in providing all round expert regulatory affairs and quality assurance consulting services for In Vitro Diagnostic Device organisations. We help clients maintain compliance with EU IVDR, UK MDR, as well as international standards. Our website also offers a range of documents and templates to assist with your compliance journey.
Economical and Pragmatic
We are a small organisation without unnecessary overheads, thereby allowing us to provide economical services to deliver your In Vitro Diagnostic Quality, Regulatory and Clinical Monitoring needs in the current financial climate.
Consulting Services
Quality Management Systems
Quality Management Systems
Quality Management Systems
FKG Consultancy can build an entire Quality Management System from scratch compliant with ISO 13485 or 21 CFR 820, perform gap analysis against an existing QMS, conduct Internal Audits or support CAPA responses from audit findings.
Regulatory Affairs
Quality Management Systems
Quality Management Systems
FKG Consultancy can provide support for regulatory strategy, compile Technical Documentation compliant with EU IVDR 2017/746 or UK Medical Device Regulations, as well as communicating with Notified Bodies or Approved Bodies. We can also support your Performance Evaluation or Labelling needs. Our areas of expertise are Biological/Chemical Assays, Companion Diagnostics, Professional Use, Near-Patient and Self-Tests.
Clinical Monitoring
Quality Management Systems
Procedures and Templates
FKG Consultancy can support your IVD Clinical Performance Study by determining the application required, compiling the documentation package and communicating with Competent Authorities. We can also provide clinical monitoring services in compliance with ISO 20916 (Good Clinical Practice for IVDs).
Procedures and Templates
Procedures and Templates
Procedures and Templates
FKG Consultancy has created an entire library of procedures, templates and checklists to support your quality and regulatory needs. Procedures provide a step-by-step process requiring minimal adaptation to suit your organisation. A free matrix is available to understand which procedures support each clause of ISO 13485. Please navigate to the Document Library to browse the documents available to purchase. Discounts are available for packages of related documents. Contact us if you require a bespoke library of documents.
Training
Procedures and Templates
Training
FKG Consultancy can provide online or in-person training to your organisation for ISO 13485, MDSAP, Internal Audits, Design Control, Risk Management, IVDR, UKCA and Good Manufacturing Practice. Contact us to enquire about your training needs.
About FKG Consultancy
Our Story
Dr. Fiona Gould, Ph.D is an IVD consultant focusing on the application of IVDR (CE Marking) and UK MDR (UKCA). She obtained her Ph.D in Cell and Molecular Biology from the University of Aberdeen (UK) in 2004 and has held positions in the pharmaceutical and medical device industries predominantly in regulatory affairs, quality assurance and project management. Fiona has taken pride in specialising in IVDs, managing extensive programs with regulatory and quality impact including IVDR transition, product development and site infrastructure. This has involved development of Technical Documentation, creation of Quality Management Systems and interaction with Notified Bodies for a broad range of device types. Furthermore, Fiona has published a White Paper with BSI on Performance Evaluation.