Medical Device Manufacturer - Design and Development

SKF.com

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SKF Medical Electronic Device Design and Certification

SKF Condition Monitoring Centre (Livingston) offers companies operating in the medical device market access to a range of proven technologies, core competencies, and established infrastructure.

We can provide as little or as much technical and engineering support as required, as well as creating tailored commercial agreements where appropriate.

This flexible combination of mobile technology building blocks, design, development, and manufacturing capability can assist new or established companies in the commercialization of innovative medical devices.

Our in-house quality, support, warranty and repair resources can ensure that these products can be fully supported throughout their lifecycle.

CMC Livingston has experience of working to medical standards, such as 60601-1 for Product Certification, and both ISO 13485 and CFR820 guidelines for Quality Systems. The company has designed, manufactured, supplied and supported mobile devices to blue chip companies worldwide.

Benefits

From concept through to design and volume manufacture
Rapid time to working prototype
Reduced development costs
Reduced time to market
Product lifecycle support
Reduced risks

Medical Certification Services and Quality

Medical device design and manufacture: ISO 13485
Electrical safety: IEC60601 (EN, US and CA deviations)
Design History File & Device Master Record
510k submission to FDA, and CE marking
SKF CMC Livingston has an IS0 9001: 2000 quality management system
Our subcontractor has an ISO 9001:2000 quality management system
SKF uses established Six Sigma methods to monitor and improve product quality

Guiding and Actuation for Medical Applications

In addition to instrumentation and electronic design skills for the medical market, SKF has also developed a unique family of guiding and actuation products and solutions for many different medical applications.

With the ideal guiding and actuation systems to meet your safety, reliability and quality requirements, most products comply with all major specifications and regulations of the medical industry, such as EN and UL approvals.

From the original concept to the launch of the product, SKF is geared towards safety and quality. SKF products are integrated into customer prototype runs and we provide thorough testing support before the system is approved for volume production.

Diagnostic imaging

In the world of managing care and saving lives, the presence of SKF contributes reliability, quality and high accuracy.

Laboratory Instruments

SKF's high-precision and low noise components can help you improve your products

Healthcare

SKF has developed a complete range of products and systems for use in a variety of healthcare applications.

SKF Medical Electronic Device Design and Certification Image

SKF Medical Electronic Device Design and Certification.

SKF has the experience and expertise to help original equipment manufacturers (OEM's) working in the medical devices market optimize product designs and reduce time to market.

Working with SKF CMC Livingston gives you access to a range of specialist engineering knowledge and services that can help make your medical instrumentation project a success.

Whether you represent a large established company, a small innovative start-up company, or even a university research project planning to �spin out', outsourcing elements of your project can often be the most cost effective, low risk option.

This is where SKF can help. We can give you flexible access to our knowledge and experience, as well as our field proven technology building blocks, manufacturing capability, and warranty / repair / support services � as appropriate to your needs.

This approach to contract engineering, contract manufacturing, and product lifecycle support, offers you a one-stop shop option.

We can become involved in your project from any point in the development process. Helping move it forward and managing the resources required to deliver a ready for manufacture design, and providing that manufacturing capability for you if required.