What is ISO 13485?

ISO 13485 is the internationally recognised standard for quality management within the medical device sector. It is based on the ISO 9001 process model and its main objective is to enable
a harmonised approach in the medical device industry. There are further requirements for the design, manufacture, servicing and installation of medical devices.

ISO 13485 is applicable to any business working in the medical device sector, helping to demonstrate that the business understands relevant regulatory requirements.

What are the benefits of ISO 13485?

The implementation of an ISO 13485 Management System will enable your company to realise a variety of benefits:

  • Customer Satisfaction – consistently deliver products and services that meet your customers’ requirements as well as meeting legal and safety requirements
  • Increase Efficiency – through the continuous improvement of processes resulting in reduced operating costs with less waste and fewer complaints
  • Legal Compliance – understand your legal requirements, the impact on your products, services and business and how to meet them
  • Improved Risk Management – with a better understanding of risk management techniques ensuring greater consistency and traceability of products
  • Improve Staff Motivation – staff will understand their roles and responsibilities enabling business improvement

Why a UKAS certified system?

UKAS (United Kingdom Accreditation Service) certified quality management system shows a commitment to quality, customers and a desire to improve efficiency.

It shows that the quality system is effective, satisfying the requirements of an external, and more importantly, independent audit.

It will give your company a competitive advantage by enhancing the company image from customers and employees and giving you a marketing edge.

Medical Device Services

  • Regulatory Affairs inc. regulatory strategies
  • Technical Files/Dossiers
  • Technical Documentation
  • Clinical Evaluations
  • Worldwide Regulatory submissions inc. CE Marking, US FDA 510(k) Premarket Clearance and Health Canada Approvals
  • Risk Management
  • Project Management
  • IRCA Lead Auditor certified
  • Supplier Qualification and Auditing
  • Process validation
  • Internal Auditing
  • Management of Complaints, Corrective/Preventive Action
  • Training