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Our Approach

Regulatory compliance is essential to meet customer as well as patients needs. It’s a complex area and becoming more complicated as technology evolves and horizontal legislation is developed. Its therefore difficult for an individual or small manufacturer to know everything.

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Compliance Connextions was founded in December 2024 to help In Vitro Diagnostic (IVD) companies navigate this tricky area.

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Sue Spencer is the Founder of the company and principal consultant. During her 38 years in the industry she has worked with many experts and developed a great network.

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The aim of Compliance Connextions will be to support IVD manufacturers navigate the regulatory maze. Sue’s expertise includes;

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  • Development of regulatory strategy for the implementation of IVDR  and UK MDR 2002

  • Strategy for tests used in clinical trial assays and CDx

  • Coaching and training in the development of technical documentation to the EU IVDR and UKMDR 2002 requirements

  • Risk management training and implementation

  • Notified body strategies and support responding to their 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

 

The regulatory landscape is large and difficult for SME’s to navigate.  If you require support to develop an FDA strategy, prepare a 510(k) or PMA preparation we will work with trusted partners to help find a suitable expert.

Meet Our Team

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Sue Spencer

Founder Director & Principal Consultant

Sue Spencer holds a BSc (Hons) Applied Biology plus over 38 years’ experience in the Medical Device and IVD industries including extensive notified body experience. During her career Sue has worked for both start up and large multinationals, where she has held positions in R&D, manufacturing, and quality assurance at a senior level. It helps to have experience in different departments in a company as this provides a more holistic oversight of the impact caused when implementing new quality systems or regulations and the importance of communicating with all stakeholders.

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Sue worked for three notified bodies establishing two from scratch. Implementing any new regulation is always an interesting time. There is the written word on paper, but it is a different skill to turn this into actionable implementation plans and to motivate teams to work together to make implementation a success.  This principle applies whether you are a Notified Body implementing a new regulation or a company introducing or simplifying a quality system or a new requirement. To be successful it requires people and tools to work together to a clear strategy to implement the requirement.

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Sue’s first love is IVDs and has worked over the last five years helping manufacturers transition to the IVD Regulation and developed a special interest in issues with the implementation of CDx and clinical trial assays in Europe and UK.

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Tom McConnell

Operations Director

Tom has a degree in Computer Science and Statistics and a 30 year career in Software Sales and Consultancy, where he specialised in business analytics and reporting.  He subsequently working as a Senior Constituency Assistant for the Independent Parliamentary Standards Authority, specialising in the NHS and Social Care, MHRA and NICE related fields of government affairs casework.

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As the Operations Director Tom is responsible for the Finance and Administration of Compliance Connextions.​​

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