Medical Device Notified Body Pre-Assessment

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.