Congratulations to V-M Orthotics Ltd for achieving ISO 13485 certification for Medical Devices!
About V-M Orthotics Ltd
Suffolk based V-M Orthotics Ltd, who celebrate their 40th year in business this year, is a provider of foot and ankle orthotic solutions within diabetic footcare, trauma, surgical recovery, physical therapy, and preventative care. Since 1985 V-M Orthotics Ltd has and continues to be dedicated to improving patient mobility and comfort to as many people as possible through innovative, high-quality medical devices.
About the Project
V-M Orthotics Ltd partnered with Assent in May 2024 to implement ISO 13485, the international standard for quality management systems in the medical device industry. The project focused on building a compliant framework and conducting internal audits to prepare for certification.
Our Approach
The project involved several members of the Assent team headed by experienced ISO 13485 consultant Sarah Smith.
Sarah worked closely with V-M Orthotics Ltd to recover lost ground, streamline processes, and ensure all requirements were met. Her proactive approach and clear guidance helped V-M Orthotics Ltd stay on track for their certification audit.
Sarah also provided support during the external audit process.
Certification Success
V-M Orthotics Ltd successfully passed their stage 2 audit in February 2025, achieving ISO 13485 certification with UKAS accredited body SGS.
Ongoing Support
V-M Orthotics Ltd have engaged the Assent Team for ongoing consultancy support to help them maintain their quality management system.
Consultant Comment:
V-M Orthotics Ltd are an organisation who are committed to quality, improvement and customer success. I have genuinely enjoyed working with Sue, Caroline and the team and I am excited to see how they move forward and enhance their new ISO 13485 QMS!
– Sarah Smith
Client Comment:
“The prospect of completing ISO 13485 was, for a small organisation such as ours, a somewhat daunting prospect. But with the supportive, friendly and professional guidance of Assent, and particularly Sarah Smith, whose knowledge and expertise were absolutely invaluable in the process, we succeeded in our accreditation goal. We thoroughly recommend their services to any company wishing to achieve this standard”.
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ISO 13485 certification for your medical device company?
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