filmov
tv
Why you need ISO 13485 for your medical device manufacturing project
Показать описание
Why you need ISO 13485 for your medical device manufacturing project?
ISO13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.
To attain this prestigious certification, we were audited by the independent firm TÜV Rhineland according to several important criteria.
- Risk Management
- Clarification of Management Responsibilities
- Enhanced Training
- Facility Improvements
- Design and Development
- Control of Suppliers
We are prepared to support you when it's time to bring your medical devices to market fast.
Our international team of engineers and technicians are dedicated to making your custom parts using the most advanced equipment and techniques including Plastic Injection Molding, CNC Machining, Pressure Die Casting, 3D Printing and Vacuum Casting. We also offer various detailed finishing services.
Our Services:
Official Website:
Subscribe to us here:
Find us at:
Facebook:
Instagram:
LinkedIn:
Are you a reader?
#starrapid #iso13485 #medicaldevicemanufacturing
ISO13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.
To attain this prestigious certification, we were audited by the independent firm TÜV Rhineland according to several important criteria.
- Risk Management
- Clarification of Management Responsibilities
- Enhanced Training
- Facility Improvements
- Design and Development
- Control of Suppliers
We are prepared to support you when it's time to bring your medical devices to market fast.
Our international team of engineers and technicians are dedicated to making your custom parts using the most advanced equipment and techniques including Plastic Injection Molding, CNC Machining, Pressure Die Casting, 3D Printing and Vacuum Casting. We also offer various detailed finishing services.
Our Services:
Official Website:
Subscribe to us here:
Find us at:
Facebook:
Instagram:
LinkedIn:
Are you a reader?
#starrapid #iso13485 #medicaldevicemanufacturing
0:05:08
Why you need ISO 13485 for your medical device manufacturing project
0:13:11
ISO 13485: What You Need to Know to Build a Quality Management Systems for Medical Devices
0:11:12
What is ISO 13485?
0:03:37
Understanding Quality Management Systems - What is ISO 13485?
0:02:37
What is ISO 13485?
0:00:32
Why ISO 13485?
0:08:28
What is ISO 13485 for medical devices?
0:10:58
When do you need to get ISO 13485 certification?
0:12:48
Why does 21 CFR 820 need to be modernized to ISO 13485?
0:02:16
Why you need ISO 13485 for your medical display manufacturing project
0:01:25
What Is ISO 13485? | Proxima CRO
0:05:59
Introduction to ISO 13485:2016 l Medical Device Quality Management System l The Learning Reservoir
0:07:01
Design control for medical devices - what is it and why you should do it
0:17:08
BIS Talks on Medical devices -- Quality management system IS/ISO 13485
1:24:32
Six steps to ISO 13485:2016 Certification and MDSAP Certification
0:02:04
ISO 9001 or ISO 13485, Which Standard Should You Work Towards As a Manufacturer or Distributor?
0:11:58
Best ISO 13485:2016 Starter Video [For Medical Devices]
0:02:58
Understanding ISO 13485
0:06:52
What's New in ISO 13485:2016
0:51:23
Practical Applications of ISO 13485 and What It Means for HTM Professionals
0:03:36
Document Control 820.40 & ISO 13485 § 4.2.1 & 4.2.4 (Executive Series #22)
0:04:40
Discover ISO 13485, the ISO Standard for medical devices
0:45:08
Training Procedure: 'Mistakes to avoid and audit advice' [ISO 13485]
0:54:25
Why ISO 13485 Matters if You’re Translating Medical Content
Комментарии