-
- News
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueCounterfeit Concerns
The distribution of counterfeit parts has become much more sophisticated in the past decade, and there's no reason to believe that trend is going to be stopping any time soon. What might crop up in the near future?
Solder Printing
In this issue, we turn a discerning eye to solder paste printing. As apertures shrink, and the requirement for multiple thicknesses of paste on the same board becomes more commonplace, consistently and accurately applying paste becomes ever more challenging.
A Culture of Thriving
One cannot simply command thriving; it must be nurtured, developed, and encouraged. In this issue, we explore strategies to improve your working relationship model—both internally and externally. In this culture of thriving, your business will grow in the process.
- Articles
- Columns
Search Console
- Links
- Media kit
||| MENU - smt007 Magazine
Top 10 Factors to Consider When Selecting a Medical EMS Company
January 13, 2016 | Mo Ohady and David Estes, Digicom ElectronicsEstimated reading time: 2 minutes
What makes for a successful contract electronics manufacturing relationship and what does a medical device company need to keep in mind and consider during the selection process?
Once the decision has been made to use an electronics manufacturing services (EMS) company, selecting the right one involves several steps. Although most EMS companies perform the same basic services, every EMS company is different. You can tell when you walk into a place, examine the equipment and processes, and speak to the people.
Number 1: Prepare a List of Requirements
The initial basis for narrowing down your selection is to prepare a list of the basic requirements you expect an EMS provider to meet and detail specifically what you want the EMS to do—design, prototyping, material selection and purchasing, manufacturing, test, process validation, shipping and logistics, etc. Do you need manual or automated processes, small quantities or volume manufacturing? Is the EMS able to offer the range of services that meet your needs?
Number 2: Certifications
Does the EMS provider have the appropriate quality certifications to manufacture the product? There is no room for error with medical devices. A basic requirement for the medical market is ISO 13485:2003, the medical device manufacturing certification. This certification states the requirements for a comprehensive management system for the design and manufacture of medical devices, ensures that medical devices meet customer and regulatory requirements, and establishes a commitment to quality. The FDA’s Quality System Regulation 21 CFR (Code of Federal Regulations) 820 requires medical device manufacturers to perform a process validation when the process is not fully verified by a subsequent inspection or test. Process validation ensures that a process consistently produces a product that meets its specifications. It is an important component in the design, prototyping, and manufacturing process and one that, if done correctly, can save a considerable amount of time, money, and resources. By using an EMS provider that already has ISO 13485:2003 certification, regulatory bodies know that certain procedures and requirements will be met, so certification is less labor-intensive and approvals proceed more easily.
Number 3: Location
Check out where the EMS is located, where design and manufacturing are done, and make sure the size of the company is a good fit for your needs and products. Do you want the product manufactured close to where your company is located, close to where the product will need to be distributed, or are you manufacturing large volumes where cost is a major factor so a low-cost geography might be more beneficial? Considerations in choosing a location are the complexity of the device, process transfer, IP protection, shipping costs and time, and the degree of involvement you will need throughout the process.
Editor's Note: This article originally appeared in the January 2016 issue of SMT Magazine.
Suggested Items
Optimizing mSAP to Produce Flex for Biofluid Sensor Probes
10/17/2024 | Dean Neuburger, Sheldahl Flexible TechnologiesImprovements in flexible printed circuitry technology offer solutions that enable advancement in other technologies, enabling new circuit design and capability possibilities for customers’ applications. This article will overview advancements developed and implemented to produce a flexible circuit that meets new and challenging requirements for a customer’s medical application. This discussion will highlight development ideas more than details about the final processing scheme.
Sales of Service Robots up 30% Worldwide
10/09/2024 | IFRSales of professional service robots increased by 30% worldwide. More than 205,000 units were registered by IFR's statistics department in 2023. Nearly 80% of the robots came from the Asia-Pacific region with 162,284 units sold. Europe followed with 33,918 units and the Americas with 8,927 units sold.
NEOTech Announces Implementation of Enhanced Wire Bonding Process to Boost Microelectronics Manufacturing Efficiency
10/08/2024 | NEOTechNEOTech, a leading provider of electronic manufacturing services (EMS), design engineering, and supply chain solutions in the high-tech industrial, medical device, and aerospace/defense markets, is excited to announce the recent implementation of an enhanced wire bonding manufacturing process for microelectronics circuit assemblies.
Global Flexible Substrate Market Size To Worth USD 2520.19 Million by 2033; CAGR Of 14.50%
07/16/2024 | Globe NewswireThe Global Flexible Substrate Market Size is to Grow from USD 650.62 Million in 2023 to USD 2520.19 Million by 2033, at a Compound Annual Growth Rate (CAGR) of 14.50% during the projected period.
Presto Engineering Achieves Medical Device ISO 13485 Quality Management Certification
07/12/2024 | Presto EngineeringThe certification covers Presto’s Denmark hub to ensure that its ASIC design and production services consistently meet medical device customer expectations and relevant regulatory requirements.