Supporting Compliance in Orthotics and Wheelchair Medical Devices
Supporting Compliance in Orthotics and Wheelchair Medical Devices
At PS Partnerships, we work closely with organisations operating in the orthotics and wheelchair medical device sector, supporting them to navigate complex regulatory requirements while maintaining a strong focus on product safety, usability and patient outcomes.
This sector presents distinct challenges. Devices are often highly customised, user‑specific and subject to continual design evolution. At the same time, manufacturers and service providers must meet robust regulatory and quality expectations, including UK and international standards.
Technical Documentation and Risk Management
We provide practical support across the full lifecycle of technical documentation. This includes the development, review and maintenance of technical files aligned with applicable medical device regulations and international best practice. Our approach ensures documentation remains proportionate, well structured and capable of standing up to regulatory scrutiny.
Risk management is a core part of this work. We help organisations establish and maintain risk management files that reflect the realities of orthotic and wheelchair use, from patient variability and environmental conditions to long‑term durability and maintenance considerations. This ensures risks are identified, evaluated and controlled in a way that is both compliant and practical.
MHRA Support and Regulatory Confidence
Engaging confidently with the MHRA is critical for organisations placing or maintaining devices on the UK market. We support customers with regulatory submissions, responses to queries and preparation for inspections or audits. This includes advising on classification, post‑market surveillance requirements and change management, helping businesses understand not just what is required, but how to implement it effectively.
ISO 13485 and Management Systems
For many organisations in this sector, a well‑implemented ISO 13485 quality management system is central to regulatory compliance and operational consistency. We support the development, implementation and improvement of ISO 13485 systems that are appropriately scaled to the organisation’s size, structure and product range.
Our focus is always on building management systems that work in practice—supporting traceability, design control, supplier management and continual improvement without unnecessary complexity.
