Specific requirements for software validation, including software using during development, manufacture and in the Quality Management System (e.g.
Emphasis on regulatory requirements (e.g.Greater requirements to manage medical device patient safety and product performance.The main changes can be categorised as follows: What Are The Main Changes Between ISO 13485 Certification 20 Versions? All manufacturers wanting the 205 certification will need to be audited against the new standard by the deadline of March 2019. ISO 13485 certification (2016) is the new revision of the Medical Devices Quality standard, published to replace ISO 13485 2003. What Is ISO 13485 2016 Transition And How Will Your Business Be Affected?
The following information may be useful in deciding whether your business needs to update your ISO 13485 certification.
Whether you are a business needing to develop an ISO 13485 system from scratch or you have existing systems, we can provide support and guidance to whatever level you require to understand the ISO 13485 certification requirements and build an effective system which suits your business. Integrated Compliance Solutions has a team of expert ISO 13485 consultants who can help your business obtain ISO 13485 certification and develop your ISO 13485 quality management systems Australia-wide. ISO 13485 consultants can provide support and advice to businesses with more challenging new requirements. This will allow a harmonised approach for medical device quality requirements across all the major regional regulators.Īs the deadline for Australian medical device manufacturers and critical suppliers transitioning to the ISO 13485 is March 2019, time is running out for small to medium sized businesses to obtain ISO 13485 certification. The new version of ISO 13485 also moves away from the structure of the latest ISO 9001 standard, to align more closely with the international medical device regulations and some requirements seen in Good Manufacturing Practice (GMP) in the pharmaceutical industry. risk management and applying ISO 14971 throughout the product life-cycle and within the QMS.transparency of product design and development.The new version of ISO 13485 was published in March 2016 in response to several globally reported medical device product failures (for example, the PIP breast implant failures).Ĭonsequently, there are significant changes in the new version to tighten quality requirements, particularly: The auditor portions (AU and TL) will continue as appropriate according to the dates scheduled.ISO 13485 Certification Transition Consultants for Your Business
The Monday of that training week will be offline and for finishing the e-learning or contacting the instructor with questions. The seated or virtual classroom portion of the class will begin on Tuesday morning with a review and testing. *FOR PUBLIC TRAINING ONLY - The requirements portion of this training is conducted online prior to the in-classroom or virtual course. This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.Īttendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units: Auditing case studies will be used to develop the required auditing skills based on ISO 19011. Other topics include audit systems, the auditing process and audit instruments the documentation process, conducting an audit, writing the audit report, and taking corrective action. This seminar fully covers the ISO 13485:2016 requirements. Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD and Exemplar Global-AU Competency Units. Register for courses 30 days in advance and get 5% off this price Note:Pricing is dependent on location and may vary.