-
- News
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueSoldering Technologies
Soldering is the heartbeat of assembly, and new developments are taking place to match the rest of the innovation in electronics. There are tried-and-true technologies for soldering. But new challenges in packaging, materials, and sustainability may be putting this key step in flux.
The Rise of Data
Analytics is a given in this industry, but the threshold is changing. If you think you're too small to invest in analytics, you may need to reconsider. So how do you do analytics better? What are the new tools, and how do you get started?
Counterfeit 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?
- 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
VDL to Produce Crucial Components for New Medical Isotope Reactor
12/18/2024 | VDL GroepVDL Groep is working to further broaden and strengthen its hightech activities. The industrial family business with its headquarters in Brainport Eindhoven is taking its first, substantial steps into the nuclear sector, a key growth market. Operating company VDL KTI in Mol, Belgium, will produce and supply crucial components for the new PALLAS reactor in Petten.
VDL to Produce Crucial Components for New Medical Isotope Reactor
12/16/2024 | VDL GroepVDL Groep is working to further broaden and strengthen its hightech activities. The industrial family business with its headquarters in Brainport Eindhoven is taking its first, substantial steps into the nuclear sector, a key growth market.
EpoxySet to Exhibit at MD&M West
12/05/2024 | epoxySetEpoxySet Inc. will be exhibiting at MD&M West on February 4-6, 2025 in the Anaheim Convention Center, booth 617.
33 Million North Americans Used Connected Care Solutions in 2023
11/27/2024 | Berg InsightA new report from the IoT analyst firm Berg Insight has found that around 33.3 million people in North America were using connected care solutions at the end of 2023.
OSI Systems Receives $11M Order for Electronic Assemblies
11/21/2024 | BUSINESS WIREOSI Systems, Inc announced that its Optoelectronics and Manufacturing division has received an order for approximately $11 million to provide critical electronic sub-assemblies for a leading-edge healthcare original equipment manufacturer (OEM), known for innovative and specialized medical solutions.