Quality Management Systems are an essential requirement for Medical Device Manufacturers and provide evidence of ongoing product quality and regulatory compliance.
ISO 13485 is a Quality Management System standard for Medical devices and specifies requirements for regulatory purposes. Based upon ISO 9001, ISO 13485 includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. This enables detailed requirements of the Medical Devices Directives to be met and provides a means of compliance with these directives.
Quality Management System reviews help to determine the current state of management systems and processes. Smithers Rapra conducts fully independent quality system reviews for companies that are either seeking to become ISO 13485 accredited or those that are already certified. We provide targeted ISO 13485 process audits in which we concentrate on specific areas where non-compliance issues have been identified.
Quality system and technical support for Medical Device Manufacturers:
- Off-Site or On-Site review of Quality Management System documentation and Master Files
- Independent, systematic process audits based upon plan, do, check, act (PDCA)
- Documented audit reports that include Gap Analyses where required
- Risk analysis to the requirements of ISO 14971
- Supplier audits related to critical materials and components
- Verification of ISO 13485 requirements within the context of the Medical Device Directive
Assessments are conducted by our expert team and headed by a lead auditor in order to accurately evaluate the compliance of your management system and opportunities for improvement.
Additional benefits of working with Smithers Rapra:
- Our team of auditors have a broad range of experience in the Medical Devices Industry, and practical experience of third party and supplier audits
- We have built long term partnerships and worked with over 70% of the world’s top 20 healthcare companies
- Access to our team of expert materials scientists and engineers who are able to provide advice on materials and process selection, and process validation
- Assistance with Failure Investigations
- Product testing to establish performance characteristics, and certification of product conformity
- We run a number of plastics and rubber training courses, including the selection of materials for Medical Devices
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Concept to Market Support for Medical Devices>
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