-
- News
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueIPC APEX EXPO 2024 Pre-show
This month’s issue devotes its pages to a comprehensive preview of the IPC APEX EXPO 2024 event. Whether your role is technical or business, if you're new-to-the-industry or seasoned veteran, you'll find value throughout this program.
Boost Your Sales
Every part of your business can be evaluated as a process, including your sales funnel. Optimizing your selling process requires a coordinated effort between marketing and sales. In this issue, industry experts in marketing and sales offer their best advice on how to boost your sales efforts.
The Cost of Rework
In this issue, we investigate rework's current state of the art. What are the root causes and how are they resolved? What is the financial impact of rework, and is it possible to eliminate it entirely without sacrificing your yields?
- Articles
- Columns
Search Console
- Links
- Events
||| 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
Absolute EMS Completes ISO 13485:2016 Recertification, Strengthening Commitment to Medical Device Quality Systems
03/25/2024 | Absolute EMS, Inc.Absolute EMS, Inc., an award-winning EMS provider of turnkey contract manufacturing services, proudly announces the successful completion of its ISO 13485:2016 audit, reaffirming its commitment to excellence in medical device manufacturing.
IMI Signs Memorandum with RRR Manufacturing PTY Ltd.
03/12/2024 | IMIIntegrated Micro-Electronics, Inc. (IMI), A memorandum of understanding (MOU) was recently signed between Integrated Micro Electronics Inc. and RRR Manufacturing PTY Ltd for the manufacture of portable automated external defibrillator solutions branded as CellAED. IMI will manufacture the full box build for the medical device that will be distributed both locally and abroad.
NEOTech Implements Advanced Technology for Enhanced Barcode Tracking in High-Tech Medical Device Production
03/08/2024 | 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 thrilled to announce the implementation of improved technology to further enhance barcode tracking in the production of high-tech medical devices.
Cicor Acquires Evolution Medtec Srl, Strengthens Engineering Capabilities in Medtech Sector
02/28/2024 | Cicor Technologies Ltd.The Cicor Group has acquired 100% of the shares of the Romanian engineering company Evolution Medtec Srl and is further expanding its engineering capabilities in the medical technology sector.
Happy’s Tech Talk #25: Lab-on-PCBs for Medical Diagnosis
02/21/2024 | Happy Holden -- Column: Happy’s Tech TalkCOVID-19 created a rush for simple and quick medical diagnostic tests for the public. Biomedical MEMS (bioMEMS) have emerged as a subset of MEMS devices for applications in biomedical research and medical microdevices, with an emphasis on mechanical parts and microfabrication technologies. Applications include disease detection, chemical monitoring, and drug delivery. There has been rapid market growth for bioMEMS technologies, and many bioMEMS devices are already commercially available. There is great potential for large-scale commercialization of microfluidic-based LoC and LoPCB technologies.