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Medical Device Design and Development

DeviceLab is a medical device design and product development firm. We help medical device manufacturers bring products to market quickly and affordably per FDA/CE regulatory requirements. Based in Southern California, we offer the following services throughout California (mainly Orange County, San Diego, Los Angeles, San Jose and San Francisco CA) and nationwide.

  • Class I, II, III Medical Device Engineers: Development and Engineering of Class 1and Class 2 medical devices, biomedical devices and some class 3 implantable devices…
  • Plastic Device Designers: Injection molded, plastic disposable device design, packaging, prototyping and manufacturing
  • Industrial Designers: Designers of medical device housing and stylistic, industrial designing via 3D computer modeling
  • Surgical Device Developers: Surgery device and electro-mechanical instrument design
  • Prototypes: Medical device prototype manufacturing services, rapid prototyping, prototype development, computer simulation videos, 3D animation, modeling, rendering, demonstration model fabrication and design for manufacturing services

We also assemble teams of 3rd party engineering firms, outsource/contractors, medical device manufacturers, development companies, RAC regulatory affairs consultants and test labs to take your medical device project from concept, through prototyping, medical device testing, qualification, pilot production and long term manufacturing. Contact our Medical Device Engineers to discuss your development needs.

Class 1, 2 & 3 Medical Devices

  • Class I Medical Device Engineering, Design and Development
  • Class II Medical Device Engineering/Developers (510k Notification via RACs)
  • Class III Medical Device Development (Selectively - PMA, IDE via RACs)
  • Specialties: Medical cart design, point of care (POC) device development, plastic disposable device engineering, handheld (hand held) device design and industrial engineering, diagnostic equipment design, disposable surgical devices, ophthalmic, therapeutic, urological, orthopedic, intravascular, cardiopulmonary, cardiovascular, circulatory and neurological medical device development, engineering and design, blood Filtration, processing, separation filtering and diagnostic devices, fluid handling and fluid analysis

Medical Device Manufacturing, Testing and FDA Compliance

  • Medical Device Manufacturing: We offer limited, pilot production and prototype medical device manufacturing services and small-scale contract manufacturing
  • Medical Device Quality and Certification: We assist clients with laboratory testing, certifications, compliance and regulatory affairs to the extent required by each project. These may include FDA requirements (510k notification, etc) , GMP/cGMPs (Good Manufacturing Practices), Quality Management Systems (QMS), QSRs, CE Mark, ISO Certification (9000, 9001, 9002, 13485…), EMC, EMI, IEC 60601 Compliance, CSA/UL registration, IEC 60601 and various FDA Cert’s and registration requirements.

Southern California Based, Worldwide Services

Based in Orange County (OC) Southern California, we are uniquely qualified to serve customers world wide. All of the required infrastructure (testing labs, FDA consultants, etc.) can be found within Southern/Northern California (CA), primarily San Diego, Orange County, Los Angeles (LA), San Jose and the San Francisco Bay Area.

Within the US, we have worked with customers and medical professionals throughout the West Coast (CA, WA, OR, AZ), Midwest (OH, IL), East Coast (NY, NJ, CT, PA) and South West/South East (TX, FL, NC, SC). Within our areas of specialty, we work with international clients in Europe (EU nations, primarily Germany, UK and France), Mexico, South America (Argentina and Brazil) and Asia (primarily China, Japan, India, Taiwan and Singapore).

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