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Purdue Manufacturing Extension Partnership (800) 877-5182 www.mep.purdue.edu ISO 13485:2016 QUALITY MANAGEMENT SYSTEMS STANDARD Overview ISO 13485 / ISO 9001 - Medical Devices Quality Management Set ISO 13485 and ISO 9001. The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development What is the purpose of ISO 13485? ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Download Free PDF. ISO 13485: 2016 Medical devices - Quality Management Systems. Academia ©2021
SUD EN ISO 13485 ISO 13485:2016 10445 March 2, 1999 April 16, 2021 Certificate Number: Certified Since: Valid Until: For and on behalf of NQA, USA Reissued: April 17, 2018 EAC Code: 17 Cycle Issued: April 17, 2018 K ISO 13485 / ISO 9001 - Medical Devices Quality Management Set ISO 13485 and ISO 9001. The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development ISO 13485:2016 Implementation Process Download a complimentary checklist (PDF) This diagram outlines the steps for your ISO 13485:2016 implementation. This easy-to-follow format shows the process at a glance, allowing you to track every stage, including: Establishing the project; Identifying customer and other requirements; Implementing support ISO 13485:2016 Design, manufacture, assembly, packaging and sales of PVC-Free medical components that meet or exceed the statutory and regulatory requirements of our customers including tubing and connectors made of PVC-Free plastics and stainless steel. All products can be assembled and manufactured within our class 7 Cleanroom. ISO 13485:2016 For and on behalf of NQA, USA K Certificate Number: EAC Code: 1762212, 19 Certified Since: July 9, 2018 Valid Until: July 8, 2021 Reissued: April 28, 2020 Cycle Issued: July 9, 2018. July 9, 2018 July 8, 2021 Certified Since: Valid Until: Reissued: April 28, 2020 NSF INTERNATIONAL 21 CFR § 820 & ISO 13485:2016 ALIGNMENT CHART Author: Robert Ruff, Executive Director, NSF International Researcher: Samuel Brown, Research Associate, NSF International This tool clarifies the corresponding relationships between the US FDA Quality System Regulation and ISO 13485… ISO 13485 is essential for any organization in the medical device and pharmaceutical supply chain.
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EMAIL i n fo@rpmed.com. I S O 13485:2003. I S O 9001:2008.
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All of the things above: ISO 13485 kits, ISO 13485 implementation guide pdf, ISO 13485 step-by-step guide pdf and ISO 13485 newsletters are all free tools to help you understand and ultimately gain certification.
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WHO SHOULD ATTEND? Professionals from Medical Device manufacturing industries, Management Representatives, Project Team Members of ISO 13485 Audit, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Process. 2021-02-06 Valid from: 2021-01-28 Valid until:Date, 2021-01-28 2023-07-08 Christoph Dicks Head of Certification/Notified Body.
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All products can be assembled and manufactured within our class 7 Cleanroom. Included you will also see an ISO 13485 Quality Policy example. It will help you to define how does this look like. Use that template to help you build a solid Quality Manual that can help you organize your company not create a wall between your employees and your system. ISO 13485, Medical devices April 6, 2021 – 12:00 Sign up for our FREE newsletters and get the top stories from MTI right in your email inbox. ISO 13485 auditor training and certification online by Punyam Academy.