Cardiac medical devices and components

medical device product development process

Navigating the cardiac market and its governing regulations for Class 1, Class II and Class III medical devices requires special knowledge and utmost care. It also requires specially designed, vertically integrated systems and absolute quality.

From design for manufacturability through delivery, your team can rely on us to:

  • Precisely produce molded components – including micro-, insert- and over-molded.
  • Produce precision machined components.
  • Consistently transform engineered, medical-grade plastics, metals and other exotic materials into implantable and handheld devices, surgical instruments, and more!
  • Repeatedly achieve extremely tight tolerances and absolute quality standards.

We also offer cost-effective “plug-and-play” SmartStack® technology. This specially designed, customizable linear contact system for active implantable devices is available for both IS4 and DF4 configurations and meets all applicable ISO requirements. Other features include:

  • Risk-mitigating design
  • Single-piece contact construction
  • Easy integration with header connector modules and leads
Donatelle conveniently offers key mating elements for a comprehensive connector solution, including complete header module and lead connector development and manufacturing.

Confidently meet the industry’s most stringent regulatory requirements, while keeping costs in check, so your cardiac medical device products will launch in spec, on time and within budget.

Expert insights

Compliance and timeline risks

Check out the Donatelle guide to learn more about “How to Avoid Compliance & Timeline Risks”

Case Study

DFM with dual prototyping paths delivers repeatable micro-features for innovative cardiovascular device

With 50-plus years of experience, we have produced millions of different cardiac medical devices and components, including:

  • Ablation systems
  • Bypass surgery (Anastomotic)
  • Defibrillators (ICD)
  • Heart pumps
  • Heart valves
  • Implantable cardiac monitoring
  • Implantable cardioverters (CHF/CRT)
  • Insertable cardiac monitoring
  • Leads
  • Pacemakers and pacing systems (IPG)
  • Pacer and defibrillator adapters
  • And more!

Bring your Class I, Class II and Class III medical device products to market with confidence. Contact us!

TUV SUD ISO 9001 logo
TUV SUD ISO 9001 logo
501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486