Changes in manufacturing processes, facility and/or Quality ManagementSystem Examples
Example
Category (Significant, non-significant)
Changes to QMS Certificate, such as:
- Change/addition/removal of manufacturing site,
- Change of scope
Significant
Change to manufacturing processes (including changes made to outsourced processes) that may affect the safety and/or performance of the medical device, such as:
- Change in the equipment used for cutting, resulting in the change in length of sutures.
- Moulding or cutting manufacturing process.
- Change of centrifugation to filtration process which results in better molecule separation.
- Change of implant manufacturing process from casting to 3D printing Change from manual operation to automatic operation, without changing the product specification.
Significant
Change in specification of registered medical device due to change in critical supplier, such as:
- Change of the supplier of the Antibody with different manufacturing process.
- Change of supplier of plastic raw material of catheter.
Significant
Changes to Manufacturing QC process issues, such as:
- Removal of two test parameter and extend acceptance criteria .
Significant
Change of zip code on the certificate, typo errors and correction
Non - Significant
Changes to Manufacturing QC process, such as:
- New QC specification with additional testing.
- Change of measuring and/or monitoring equipment without changing test parameter.
Non - Significant
Change in non-critical supplier that extrudes the polymer tubing with no change in finished product performance specifications.
Non - Significant
Talisium is a Registered Trademark of Talisium Pty Ltd
Sahjogita Kathuria
Sahjogita Kathuria is Director Regulatory Affairs and Quality Assurance in Terumo India Pvt. Ltd.
She joined Terumo in 2017 and has a total of 17 years experience in RA/QA. At Terumo her responsibility is to ensure organizational effectiveness by providing leadership for the RA/QA function.
In her previous experience, she worked with CR BARD, Sanofi Pasture, BAXTER and RANBAXY and has experience in medical devices, biologicals, vaccines and new drugs.
Sahjogita is a certified lead auditor for Medical Device Quality Management System ISO – 13485:2016 and a certified internal auditor ISO – 9001:2008.
She is actively engaged in various medical device industry forums and is part of the core group for APACMed capacity building group.
Recently, she played a very important part in creating an exclusive forum for Japanese healthcare companies in India named Japan Medical Device Association in India (JMDAI).
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Our complete Accessibility Conformance Statement can be found on our website.
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Access Keys
Access keys let you navigate around the e-learning session without using a mouse or other pointing device.
Table of Access Keys Used
Access keys are intended to provide an alternative form of navigation by using keyboard shortcuts. Please note that only numeric keys have been used in this e-learning session, in an effort to provide the alternative navigtation while not conflicting with any other software that may use access keys or any access keys already defined by the user themselves.
Some assistive technology tools such as the IBM HomePage Reader and WindowEyes already make use of the alt+[access key] combinations. As such, users of these tools may not be able to use some of these access keys.
- 0 - open this Access Keys Help page (this page). This web page opens in a new window.
- 1 - go to the first page of this e-learning session.
- 2 - skip to main content of current page.
- 3 - open the menu.
- 4 - go to the previous page in current session.
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How to use Access Keys in your Browser
- Internet Explorer 8 and above (PC)- Hold down the ALT key and the access key. In some cases you may find that you need to hold down the ALT key with the access key and then release both keys and press ENTER.
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Author Umesh Dashora
Royal College of Physicians
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project. Principal copyright holders for ACUMEN project.
Royal College of Physicians of Edinburgh
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project.
Royal College of Physicians and Surgeons of Glasgow
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project.
