Introduction
Facing Audit Findings or Non-Conformance?
QAEC Limited help medical device and IVD manufacturers resolve non-conformances, implement effective corrective and preventive action CAPA systems, and maintain compliance with ISO 13485, ISO 9001, EU MDR 2017/745, IVDR 2017/746, UK MDR 2002, and FDA 21 CFR 820 requirements, in parallel with ISO 14971.
Whether you are a start-up or an established manufacturer, we provide specialist non-conformance CAPA support tailored to your organisation.
Managing non-conformances is critical to patient safety, regulatory compliance, and your organisation’s reputation. If left unresolved, they may lead to field safety corrective actions (FSCAs), product recalls, penalties, or the loss of CE and UKCA certification, restricting market access.
We understand how disruptive audit findings and non-conformances can be, and these issues often arise during notified body, MHRA or FDA inspections.
Our approach is practical and transparent, helping you identify root causes, containment actions, document findings, and implement effective CAPA actions that meet regulatory requirements as part of risk management. We ensure that your responses are proportionate, compliant, and well-documented.
With the right strategy plan, you can address findings, protect your product design and approvals, and strengthen your QMS to reduce future risk and maintain uninterrupted market access.
We are here to support you at every step.
How can we help?
Non-Conformance Support Services
- Reviewing notified body, MHRA or FDA inspection findings, providing feedback with clear actionable remediation plans, including structured root cause analysis for medical device and IVD non-conformances.
- Developing practical, proportionate CAPAs, including a CAPA procedure to correct issues, prevent recurrence, and verify effectiveness.
- Preparing clear and compliant documentation for notified body, MHRA or FDA responses, ensuring that evidence aligns to ISO 13485 and regulatory requirements.
- Supporting your internal teams to close non-conformances efficiently and maintain ongoing compliance with ISO 13485, ISO 9001, EU MDR 2017/745, EU IVDR 2017/746, UK MDR 2002, and FDA 21 CFR 820.
- Managing and auditing your QMS as an extension of your team, identifying risks, environmental controls, closing system gaps, and ensuring audit readiness for regulators and certification bodies.
A robust Quality Management System reduces non-conformances and unforeseen risks, strengthens audit readiness, and ensures the safety and reliability of your medical devices and IVDs.
Company Insights
What Our Clients Say
“
Medical Device Sector
Charles was extremely accommodating, in that he was able to step into a Quality Manager position temporarily. He quickly established a good working relationship with the team and provided the necessary support across both QC and QA functions.
His knowledge of our industry and, therefore, our Regulatory requirements was excellent, and his input for potential future improvements provided a valued insight. The team were grateful for his support and took on board his forward-thinking approach.
“
MedTech Sector
Ed provided expert guidance and support for a number of quality, regulatory and design/development process improvements. Ed also provided hands-on input to process and document creation and review activities.
Ed clearly has extensive and relevant experience and is a subject matter expert on quality and regulatory matters relating to the development and market approval of medical devices.
“
MedTech Sector
QAEC Limited provided Quality Assurance and Regulatory Affairs support services in relation to Internal Audits, MDR 2017/745 related activities and other QARA support functions as necessary, working closely with my team within Quality and Regulatory successfully addressing and meeting our set objectives.
I would highly recommend Charles (Ed) Spearpoint, QARA Consultant at QAEC Limited, for his expertise and flexible and helpful approach, as he was a pleasure to work with. QAEC Limited are a great company, very efficient and professional.
“
Medical Device Sector
As Lead MDR Consultant, Ed worked closely alongside myself and my team within QA, to initially conduct a gap analysis approach against the requirements of MDR 2017/745 and then to lead and support remediation of corresponding procedures and processes in collaboration with departments and SMEs within our organisation.
During his time on site, Ed demonstrated a thorough understanding and working knowledge of the MDR 2017/745 regulation, its interaction with our ISO13485: 2016 Quality Management System, and all associated elements.
“
HealthTech Sector
Charles (Ed) Spearpoint assisted with the daily handling of our QA Departments and assisted in supporting our FDA remediation. Ed has shown a very high level of quality in his work and his approach. He has given the organisation a fresh breath, and he contributed with professional participation, being a part of both my Worldwide QA team and the local management team.
Ed has shown strong leadership and you can clearly feel he is very experienced in this area. I only have positive feedback to give around Ed and will recommend him anytime.
“
Biopharmaceutical Sector
Charles (Ed) Spearpoint was utilised in a support capacity in our transition project from MDD to EU MDR 2017/745 for Medical Devices. Ed provided technical guidance, support and direction coupled with key tasks involved in the compilation of the identified technical files.
He has been proactive and has worked collaboratively within the business to bring about the deliverables in meeting the regulations, bringing challenge to what is actually required against the new regulations and how this is embedded within the standard ways of working within our business, successfully navigating areas of complexity and ambiguity. As part of his role, Ed has also rolled out awareness training aligned to MDR 2017/745.
“
In Vitro Diagnostic Sector
Charles Spearpoint's consulting services were used by us to assist in the implementation of the MDSAP standard.
With Charles’s guidance, we successfully went through the first stage audits for MDSAP and successfully went through certificate renewal for ISO 13485: 2016, ISO 9001: 2015 and the Medical Device Directive.
With Charles’s assistance we are in a far more stronger position for compliance and regulatory activities. We will use QAEC Limited consulting services again when required and would recommend their services to other companies.
“
Medical Device Sector
Charles was extremely accommodating, in that he was able to step into a Quality Manager position temporarily. He quickly established a good working relationship with the team and provided the necessary support across both QC and QA functions.
His knowledge of our industry and, therefore, our Regulatory requirements was excellent, and his input for potential future improvements provided a valued insight. The team were grateful for his support and took on board his forward-thinking approach.
“
MedTech Sector
Ed provided expert guidance and support for a number of quality, regulatory and design/development process improvements. Ed also provided hands-on input to process and document creation and review activities.
Ed clearly has extensive and relevant experience and is a subject matter expert on quality and regulatory matters relating to the development and market approval of medical devices.
“
MedTech Sector
QAEC Limited provided Quality Assurance and Regulatory Affairs support services in relation to Internal Audits, MDR 2017/745 related activities and other QARA support functions as necessary, working closely with my team within Quality and Regulatory successfully addressing and meeting our set objectives.
I would highly recommend Charles (Ed) Spearpoint, QARA Consultant at QAEC Limited, for his expertise and flexible and helpful approach, as he was a pleasure to work with. QAEC Limited are a great company, very efficient and professional.
“
Medical Device Sector
As Lead MDR Consultant, Ed worked closely alongside myself and my team within QA, to initially conduct a gap analysis approach against the requirements of MDR 2017/745 and then to lead and support remediation of corresponding procedures and processes in collaboration with departments and SMEs within our organisation.
During his time on site, Ed demonstrated a thorough understanding and working knowledge of the MDR 2017/745 regulation, its interaction with our ISO13485: 2016 Quality Management System, and all associated elements.
“
HealthTech Sector
Charles (Ed) Spearpoint assisted with the daily handling of our QA Departments and assisted in supporting our FDA remediation. Ed has shown a very high level of quality in his work and his approach. He has given the organisation a fresh breath, and he contributed with professional participation, being a part of both my Worldwide QA team and the local management team.
Ed has shown strong leadership and you can clearly feel he is very experienced in this area. I only have positive feedback to give around Ed and will recommend him anytime.
“
Biopharmaceutical Sector
Charles (Ed) Spearpoint was utilised in a support capacity in our transition project from MDD to EU MDR 2017/745 for Medical Devices. Ed provided technical guidance, support and direction coupled with key tasks involved in the compilation of the identified technical files.
He has been proactive and has worked collaboratively within the business to bring about the deliverables in meeting the regulations, bringing challenge to what is actually required against the new regulations and how this is embedded within the standard ways of working within our business, successfully navigating areas of complexity and ambiguity. As part of his role, Ed has also rolled out awareness training aligned to MDR 2017/745.
“
In Vitro Diagnostic Sector
Charles Spearpoint's consulting services were used by us to assist in the implementation of the MDSAP standard.
With Charles’s guidance, we successfully went through the first stage audits for MDSAP and successfully went through certificate renewal for ISO 13485: 2016, ISO 9001: 2015 and the Medical Device Directive.
With Charles’s assistance we are in a far more stronger position for compliance and regulatory activities. We will use QAEC Limited consulting services again when required and would recommend their services to other companies.
Get Compliance Clarity
Why Choose Us
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Proven Track Record
Global expertise in quality assurance and regulatory affairs for a variety of industries, ensuring global regulatory standards are met.
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Customised Solutions
Tailored consultancy to meet your specific business needs.
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MDR and IVDR Experts
Successful transition to MDR 2017/745 and IVDR 2017/746
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End-to-End Support
From setup and validation to ongoing audit support, we ensure continuous compliance and quality.
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Our Flexible Resource
Monthly retainer, short-term, interim, or long-term quality or regulatory support, we can help you meet your goals cost-effectively.
