1/2/2023 0 Comments Iso 13485 qms![]() Additionally, our Information Security Management System is also certified with the requirements of ISO 27001 standard. Consequently our Clients work together with us on the platform, and have all the required documents and records delivered at the agreed project milestones. Pro4People’s QMS operates on ins2outs platform – an online Organization Management System used in essence to execute daily project activities. Even though we usually follow Clients’ Risk Management System (RMS) in Design and Development, we do make sure that every team member is aware of, and competent in that domain, crucial for medical device development. Our QMS also fulfils the requirements of ISO 14971 – Medical Devices – Application of risk management to medical device standard. “Design and Development and Service Provision of medical device and health software for medical device manufacturers.” A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a. ![]() The scope of our certification is defined as Our QMS has been certified by Lloyd’s Register. We are specialized to support companies to fast and efficiently pass audits.Our SDLC service operates under the ISO 13485 certified Quality Management System. The end result was a more robust, hybrid QMS that is certified to both standards. We also incorporated device master records and device history records into our quality control plans. Excluding Canada, the application of ISO 13485 is not a requirement but is the de facto standard in use today as a measurement of full QMS compliance set forth on medical device regulations. As we adapted our ISO 9001 QMS to comply with ISO 13485, we implemented risk analysis, process validation, and product recall procedures. If you need any help in this road, just contact us. In short, ISO 13485 is an internationally recognized standard that the following countries have adopted: Europe, Canada, Australia and other markets. If you passed the audit successfully you will obtain the certificate(s). Your notified body will audit your company for two to ten (or even more) days depending on the size of your organization. Are you a supplier to medical device manufacturers Do your customers demand the ISO 13485.
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