What is Compliance Connextions Limited?
​
The aim of Compliance Connextions is to provide quality management system and regulatory support to the In Vitro Diagnostic industry.
The primary focus of the company is to support manufacturers introduce safe and effective IVDs into the European and United Kingdom markets. Compliance Connextions will provide practical advice based on over 30 years of experience.
Who is Compliance Connextions Limited?
​
Sue Spencer
Sue is the founder of the company she has an established reputation in the IVD industry, holding senior positions with both manufacturers and Notified Bodies.
Sue has developed a network of experts and connections across the industry and aims to leverage this to support SMEs navigate the regulatory maze.
Follow us on Linkedin
Tom McConnell
Sue is supported by her husband Tom McConnell who had a lengthy career in analytical software including technical applications and sales before becoming a Senior Constituency Assistant for a local MP. Tom has experience running an efficient office and is a great support to the business.
Follow us on Linkedin
What was the motivation to start the business?
Over 90% of manufacturers in the IVD sector are SMEs and as a result may not have the network to find the right consultants at the right price. Appropriate engagement at the right time in a device’s life cycle can save companies time and therefore money by ensuring that devices meet the regulatory requirements and prevent reinventing the wheel.
No matter what the size of the company it is important to provide consultancy that enables manufacturers to understand regulatory and quality expectations in a way that makes sense and is therefore actionable to their situation. Our aim Is to use our experience to provide a holistic view to enable efficient and effective strategies to e developed.
The company includes the word Connextions in its title, it Is difficult for anyone to be an expert in every aspect of IVD regulations world-wide so part of the company ethos will be to help you find the right support wherever possible.
What are our areas of expertise?
​
-
Development of regulatory strategy for the implementation of IVDR and UK MDR 2002 including clinical trial assays and companion diagnostics (CDx),
-
Coaching and training to support the development of technical documentation to the EU IVDR and UKMDR 2002,
-
Risk management training and implementation,
-
Notified body strategies and support responding to NB questions,
-
Development and implementation of quality management systems for IVD companies,
-
IVDR readiness audits,
-
Preparing sites for notified body audits or FDA inspections,
-
Due Diligence reviews and audits.