This is the first part of a three-part series focused on the changes between ISO 13845:2003 and ISO 13485:2016. The second and third parts of this series will be featured in upcoming issues of Today’s Medical Developments.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.
The new ISO 13485:2016 standard is more focused on identification of interested parties and their expectations and the implementation of a process-based system for planning, monitoring, and improvement of the overall quality management system. It requires additional emphasis on identification and monitoring of all suppliers’ processes to ensure that the overall company objectives are met. This includes industry-specific specialists responsible for raw materials, plastics processing, and precision tooling as well as suppliers to the medical device industry.
Successful suppliers know their customers’ needs and fulfill requirements because they control their processes and ensure quality. A tool for managing an organization and improving performance, it acts as a quality management system that identifies opportunities for improvement and fulfills the requirements of customers and suppliers, allowing organizations to optimize their processes while reducing costs.
For smaller organizations, survival in today’s economy relies upon ISO 13485 certification. Organizations are turning toward this certification to control the quality and effectiveness of management systems and reduce costs associated with poor quality. Some seek certification because their clients demand it or because their competitors are certified. Others become certified to grow market share and sell overseas. A company’s ISO industry-specific specialist has a monumental responsibility to know the business, both operationally and financially, to improve performance reporting.
These services are customized to meet the needs of each supplier, requiring a background in supporting clients with supplier and process assessments for improvements and audits. Clients access their expertise and global footprint to gain relevant information quickly and cost-effectively.
An ISO industry-specific specialist will provide an independent and expert assessment of a company’s management system, assuring top management that the system conforms to the requirements of the standard. The insight gained from an assessment/audit on whether the management system is suitable for achieving the desired results is important. The specialist will suggest improvements and support the decision-making process.
Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. Yasenchak can be reached at email@example.com or 706.694.2977.
Osstem Implant selects License to Cure for Medical Device
Dassault Systèmes’ industry solution experience to expand in global markets; 3DEXPERIENCE platform helps dental implant company accelerate innovation, regulatory approval.
The medical device industry has been plagued by safety and quality issues and product recalls that have led to increased regulatory scrutiny. As a result, many companies must dedicate more research and development expenditures to regulatory activities than to new product introductions.
Osstem Implant, with 22 offices worldwide and manufacturing facilities in the U.S. and South Korea, looked to expand its market share by balancing regulatory requirements with innovation. Specifically, it sought a unified, digital platform to manage unique device identifier (UDI), design change and quality assurance information it submits to regulatory approval organizations such as the U.S. Food and Drug Administration.
Based on the 3DEXPERIENCE platform, the “License to Cure for Medical Device” industry solution experience provides a collaborative, integrated business framework that accelerates the delivery of innovative, safe, and fully compliant medical devices. By eliminating traditionally disconnected processes and data, Osstem Implant has access to a single source of information and an end-to-end, traceable and compliant product development process directly linked to quality management. This helps minimize time to market and regulatory overhead.
“We selected Dassault Systèmes’ ‘License to Cure for Medical Device’ to help us better manage regulatory activities and new product development as we expand internationally and must meet different market requirements,” said Tae-Yong Kim, head of information system management team, Osstem Implant. “We can improve product development and project management efficiency and streamline the regulatory filing process for our dental implant solutions.”
“The ‘License to Cure for Medical Device’ industry solution experience transforms regulatory from a constraint into an asset and allows the organization to optimize quality and compliance efforts and reduce cost and time to market,” said Jean Colombel, vice president life sciences industry, Dassault Systèmes. “With a collaborative, end-to-end, fully traceable, fully compliant product development process that is directly linked to quality and regulatory information, companies can meet project challenges and accelerate the creation of advanced solutions for human health.”
Source: Dassault Systèmes
Okuma partners with CPCC to train employees
Central Piedmont Community College (CPCC) to provide specialized CNC machine tool training for Okuma’s workforce.
Charlotte, North Carolina – Okuma America Corporation is partnering with Central Piedmont Community College (CPCC) to provide customized machine tool training for Okuma employees. The program is funded through North Carolina’s NCWorks Customized Training Program and is implemented through the North Carolina Community College System.
Okuma recently expanded its mechanical repair and exchange service departments in Charlotte and is receiving $63,310 in CNC training from CPCC to train new hires and current employees. The training programs include leadership, process improvement, SolidWorks, computer operations, electrical assembly and wiring, and enterprise resource planning.
The training grant supports economic development efforts of the state of North Carolina by providing education, training and support services for eligible businesses, assisting them in their efforts to be productive and profitable within the state.
“This unique training program provides Okuma's current and future workforce with the skills necessary to be successful in their careers," said Brittany Russell, Okuma America, training program manager. "Our partnership with CPCC is yet another way for us to help ensure the future success and growth of manufacturing in the Charlotte area.”
“CPCC is delighted and honored to work with Okuma America as the company expands its operations in Mecklenburg County,” said Allison Bowers, CPCC director, economic recruitment. “The college, through our Corporate Learning Center, will work hard to deliver the customized training Okuma associates need now and in the future.”
Chicago, Illinois - Adaptive Post-Processing is a new technology developed that allows CAD/CAM users to concentrate on programming for the production part and less on the targeted machine tool. Adaptive Post-Processing can post-process the programmed CAM part program for the selected machine tool, automatically remove machine over-travels, remove air-cut motions, eliminate collisions with in-process stock, optimize feed-rate based on the user’s tool/material specifications and simulate the produced G-code - all in one single concurrent process.
This unique integrated process removes the usual multiple iterations required in traditional manufacturing solutions that incorporate a sequential process including CAM programming, post-processing, G-code machine simulation, error reporting and back to CAM programming. Adaptive Post-Processing also offers complete flexibility to move a 5-axis manufacturing program to differing machines equipped with different controllers and machine kinematics.
Adaptive Post-Processing automatically adapts the CAM tool-path program to the selected CNC machine, dramatically reducing (25% - 35%) both programming time as well as machine cycle time.
About the speaker
Jean-Nicolas has been involved in CAD/CAM since 1987, working at different companies such as Dassault Systemes, Cadkey, Missler Software and ICAM Technologies.
Through the different years and CAD-CAM manufacturer companies, he worked for; Jean-Nicolas has been in charge of technical support, business development and technical marketing depending on the company. During the year 2002-2004, Jean-Nicolas was representing Canada for the TC184/SC4. STEP (ISO 10303) in geometry representation comity.
Jean-Nicolas started to work at ICAM Technologies in June 2006 to be Technical Support Manager in charge of the support group for post-processing & machine simulation, in 2010 Jean-Nicolas took the position of Director of ICAM China Business Unit and Director of Strategic Marketing. Since January 2014, Jean-Nicolas Vice President of Technical Marketing and Support Services at ICAM Technologies.
Florence, Kentucky – Manufacturing technology leader Mazak Corporation has announced that Brian Papke, long-time company president, has accepted a new position as chairman, and Daniel Janka, former executive vice president, has been named company president. On July, 1, 2016, Janka assumed the normal operating functions of Mazak’s North American operations, including Mazak’s iSMART Factory and North American Headquarters in Kentucky along with the company’s eight Technology Centers located throughout North America.
With these new appointments, Mazak positions itself for continued future growth and further strengthens its Rock Solid industry reputation. This next generation of leadership together with the entire Mazak team will continue the company’s forward momentum and pioneering spirit in the manufacturing industry’s new digital frontier. It will also further strengthen the company’s industry dominance in multitasking, 5-axis and additive manufacturing technologies. This seamless leadership transition will also ensure customers continue to receive the machine tool industry’s most comprehensive service and support as well as the latest most advanced machine tool technology.
Papke personally selected Janka who joined Mazak in early 2016. Janka’s experience in the machine tool industry and his extensive involvement with machine tool utilization software and 5-axis technology at past positions meshes well with Mazak’s iSMART Factory and the company’s commitment to MTConnect as well as the total Mazak iSMART manufacturing concept.
Papke has been with Mazak since 1987 and company president since 1989. Under his leadership, the Kentucky plant grew from one building to its current five-building, 800,000ft2 campus where the company now designs and builds some of the industry’s most advanced manufacturing systems, including innovative full 5-axis and Multi-Tasking machines – and most recently, the introduction of Mazak’s iSMART Factory Concept and the Mazak SmartBox that allow for the further integration of digital solutions in manufacturing.
About Mazak Corporation Mazak Corp. is a leader in the design and manufacture of productive machine tool solutions. Committed to being a partner to customers with innovative technology, its world-class facility in Florence, Kentucky, produces more than 100 models of turning centers, Multi-tasking machines and vertical machining centers, including 5- axis models. Continuously investing in manufacturing technology allows the Kentucky Mazak iSMART Factory to be the most advanced and efficient in the industry, providing high-quality and reliable products through its “Production-On-Demand” practice. Mazak maintains eight Technology Centers across North America to provide local hands-on applications, service and sales support to customers.