Involved in the design, production, installation or servicing of medical devices?
Then you’ll no doubt be very familiar with the regulatory compliance associated with ISO 13485.
But, in an industry where ‘safety and quality are non-negotiable‘ and ‘organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do’ regardless of size or type, how do you ensure medical device design and manufacture is monitored and managed in real-time?
Join Proximity on Thursday 26 September at 10:00am (BST) for a webinar which not only covers an overview of ISO 13485, we’ll also provide practical ways for medical device manufacturers to apply DELMIAWORKS manufacturing software to drive real-time quality, traceability, accurate product identification and efficiency.
During the webinar you’ll learn more about:
- What ISO 13485 means to your medical device manufacturing business
- How you can prepare
- How technology can be used to drive real-time quality, traceability, accurate product identification, in support of ISO 13485.
As well as providing tools and capabilities to meet ISO 13485 compliance standards, DELMIAWORKS helps medical device manufacturers to address:
- ISO 9001
- Current Good Manufacturing Practice (CGMP)
- CFR and FDA requirements
- Secure electronic signature and document control to comply with 21 CFR Part 11.
What does ISO 13485 cover?
The latest iteration of ISO 13485 came into effect earlier this year and is an internationally agreed standard that specifies requirements for a quality management system specific to the medical devices industry.
Not only can the standard be used by organisations for certification purposes, it can also be used by businesses across the supply chain that are required by contract to conform – opening up opportunities to do business internationally and gain competitive advantage.
ISO 13485:2016 helps manufacturers to design and operate a quality management system that ‘establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market’.
ISO 13485:2016 places ‘ greater emphasis on risk management and risk-based decision making for processes outside the realm of product realisation’ compared to its 2003 version by focussing on the risks associated with the safety and performance of medical devices, plus compliance with regulatory requirements across the entire supply chain.
Interestingly, the new standard also includes:
‘Harmonisation of validation requirements for different software applications, such as QMS software, process control software, software for monitoring and measurement’.
How has DELMIAWORKS helped other medical device manufacturers with compliance?
Manufacturing from two state-of-the-art facilities in Long Island, New York and a third in New Jersey, Natech Plastics provides engineering, custom injection moulding and contract manufacturing for the medical device, consumer packaging, and electronics industries.
Founded by German-trained Master Toolmaker, Gerd Nagler in 1998, the business is still family-owned. Like other customers, those of Natech Plastics demanded high-precision, tight-tolerance medical devices, which had an associated high cost of failure.
Continued growth in the business put increased pressure on their existing, legacy ERP system. Employees were required to manually handle many of the operational processes with machine scheduling a particular pain point as those manual processes were both difficult and time consuming.
Following a competitive review, Natech selected DELMIAWORKS’ end-to-end ERP Software & real-time production monitoring system based on their:
- Expertise in supporting injection molding processes
- Positive recommendations from the Manufacturers Association for Plastic Processors (MAPP) network
- Pre-defined BOMs (Bill of Materials) which met their injection moulding
- Ability to handle simple, complex, progressive and multi-cavity family tooling (particularly important considering the background of the company founder)
- Ability to manage complex scheduling requirements easily and monitor the shop floor in real-time to get an accurate view of production.
Having achieved ISO 9001 back in 2003, they added ISO 13485 in 2019.
David Kachoui, director of business development at Natech Plastics commented:
“DELMIAWORKS understands our industry, has earned the trust of the industry, and provides the capabilities to support our operations. We are excited to automate much of our previous manual work with DELMIAWORKS, which will help to make our processes faster, less risky, and more streamlined.”
Learn more about DELMIAWORKS
Formerly known as IQMS, DELMIAWORKS manufacturing software & production monitoring system is a Dassault Systèmes product and forms part of its 3DEXPERIENCE, providing plastics manufacturers of all types with a cost-effective operational management system.
DELMIAWORKS, in combination with Dassault Systèmes’ SOLIDWORKS product, provides a unique closed loop manufacturing system, from design, production scheduling, manufacturing and real-time shop floor control.
With the needs of plastic injection moulding & extrusion; metal stamping, fabrication & cutting; assembly; packaging; and die cast manufacturing processes in mind, the DELMIAWORKS platform spans design; ERP, including accounting, sales orders, material requirements, inventory, and purchasing; and extended manufacturing functionality for production scheduling, shop floor control, quality control, and warehouse management.