(888) 860-1193

https://www.ventureoutsource.com/contract-manufacturing/search/industry-markets/medical-electronics-services

Find Medical Electronics Services Near You

Medical electronics service providers specialize in meeting OEM customer needs serving a constantly innovating and government regulated market. VentureOutsource.com offers a free service to help medical OEMs expand your options. Call us at (888) 860-1193 and ask to speak with a Provider Advisor about medical electronics service providers. Its free! You can also expand your criteria here, when seeking medical electronics services.

RELATED DOCUMENTS
Contract Agreement for EMS Medical Device Design Services (7 pages)
Contract Agreement for EMS Medical Device Manufacturing Services (14 pages)
OEM RFQ Terms & Strategy Clauses Presented to EMS Provider
OEM Terms & Strategy for Program Transfer to EMS Factory
Contract Agreement for EMS Electronics Design Services (7 pages)

Understanding medical electronics services

Electronics providers specializing in medical electronics jump through a few more hoops to qualify serving your program needs. Medical electronics / devices are categorized into three classes by the U.S. Food and Drug Administration (FDA), Class I, II and III. Classification is based on risk to the user / patient with Class I posing the lowest risk, Class III the highest.

We can help expand your option for medical electronics services

Providers offering services for FDA compliant products must have their facilities FDA certified. Providers with international manufacturing locations will have obtained FDA registration and ISO 13485/88 certification.  Some trends in the medical electronics marketplace from the needs of consumers are driven by the demand for increasing at-home healthcare product functionality, smaller product footprints and lighter weight of finished goods amid people wanting to live longer, independent and healthier lives.

Find medical electronics design services
Go

In your search results, you will be able to further target provider options by choosing services, then selecting Go.

JUMP TO: Services offed by medical electronics providers | How to find medical electronics providers

YOUR ONE-STOP ELECTRONICS SERVICES DIRECTORY

One of our goals is to make it easy for electronics sourcing decision makers just like you to find quality electronics services. Our unique and extensive interactive marketplace of provider services helps you easily find, connect and target the electronics provider companies you need, exactly when you need them.

For any electronics industry market, get prepared to find your next contract electronics provider with us.

Aerospace & Avionics | Defense & Military | Industrial | Consumer Devices | Computing | Medical | Clean, Green Technology | Automotive | Networking Equipment | Telecom | Servers & Storage | Peripherals

MEDICAL ELECTRONICS REGULATORY & QUALITY COMPLIANCE

Providers offering services for FDA compliant products must have their facilities FDA certified. Providers with international manufacturing locations will have obtained FDA registration and ISO 13485/88 certification. Due to the nature of medical products electronics service providers serving this fast-growing market must have robust quality assurance systems. QSAs can include:

  • Certification to ISO 9001:2008*, ISO 13485:2003
  • Compliant to cGMP
  • Compliant to FDA Quality System Regulation (QSRs) 21 CFR 820

*13485:2003 outlines specs for a provider’s QMS where he has demonstrated capability to offer OEMs consistently high quality medical device and related services meeting customer requirements and FDA regulatory requirements for such devices and related services.

Find medical electronics NPI services
Go

 

ISO 9001:2008 & ISO 13485:2003
ISO 13485:2003’s main objective is to help medical providers focus particular attention on medical devices / electronics, taking into account the broader ISO 9001 quality certification (but excluding some 9001 spec requirements not appropriate as requirements regulated by the FDA).

Providers with international medical facilities administered through a QMS (international standard) for medical devices cannot claim conformity to ISO 9001 unless their QMS conforms to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Medical electronics product recalls can have a far greater sense of urgency than, say, a smarthphone. Compliant providers must be able to quickly and accurately identify faulty product in the field because human lives could be at risk. One way to help address this, medical electronics providers have sophisticated electronic document approval and storage systems requiring proper validation throughout the supply chain. For more ideas about OEMs working with medical electronics provider see, Outsourcing benefits in medical electronics.

Find medical electronics ODM services
Go

Importance of 510(k) clearance knowledge
The Food, Drug and Cosmetic Act Section 510(k) mandates OEMs marketing medical devices need to register / notify the FDA at least 90 days in advance of the date the OEM intends to bring its medical device to market.

The ‘premarket notification’ (or PMN) provides the FDA adequate time for deciding if the OEM’s device is similar to any of the products / devices currently in one of the three classifications for medical devices mentioned above. This allows the FDA to better identify ‘new’ devices coming into the market and, submitting the proper PMN paperwork is important, as is understanding the 510(k) process and sequence of events.

Find medical electronics prototyping services
Go

New (first-time-to-market) product and/or product re-introduced to market for commercial use, but with a considerable amount of change modifications (to the point where the product’s use for safety or it’s effectiveness could be impacted) such as changes related to product design, materials used, power source, manufacturing process, or intended use…must be processed through 510(k) clearance.

Its easy for medical OEMs to understand the importance of partnering with medical electronics providers knowledgeable of the 510(k) cannot be underrated.

SERVICES OFFERED BY MEDICAL ELECTRONICS PROVIDERS

The types of services offered by providers serving the medical electronics market can vary. A few of the common services include:

  • Engineering, electrical systems development and test
  • Product concept manipulation and prototyping
  • PCB layout, DfM, and functionality test
  • Tooling and injection molding
  • Box build, systems integration

 

Materials and parts procurement, BOM analysis, field failure support with both RMA and reverse logistics services plus many more are also offered. Here’s an article on how to get more accurate quotes for electronics services during your RFQ process.

Find medical electronics manufacturing services
Go

HOW TO FIND MEDICAL ELECTRONICS PROVIDERS

To find a medical electronics services provider in your region you have interest in, search by geography here in the VentureOutsource.com Medical Electronics Services Directory. You can use the inset below if you’d like help expanding your provider options. Also, be sure to check reviews of medical services written by other professionals. Add your review for providers you have experience with.

Want help to expand your provider choices?

Once you’ve created your short list, check out this checklist on evaluating electronics providers as well as this sample contract agreement on medical electronics design between an OEM and medical contract electronics provider. In addition to visiting medical electronics providers and visiting with their management team, it will be in your best interest to still ask for references. If you still want help, we offer a free service to OEMs. You can call us and speak with a Provider Advisor at (888) 860-1193.

Also, to learn more about medical electronics services and working with providers offering medical electronics services you’re welcome to register with our community where you can seek other, like-minded professionals.

Join the conversation.

 

You might also like:

How to: 14 Steps to Select EMS Manufacturing Partners

 
About VentureOutsource.com

VentureOutsource.com is the leading online destination helping electronics OEM decision makers make more informed decisions and reduce risk. We offer educational Webinars, thousands of original articles and helpful tools, a community of influencers who understand the challenges facing your company today, and a comprehensive directory of electronics provider services.



Copyright Venture Outsource, LLC. All Rights Reserved
The material on this site is for informational purposes only and is not a substitute for legal, financial or professional advice. Distribution and use of this material are governed by our User Terms Agreement and by copyright law. By using our Website you agree to site Terms and Privacy policies. For questions please contact VentureOutsource.com at 1-888-860-1193 or visit www.ventureoutsource.com