About Us Medical Markets Capabilities Case Studies Expert Insights Careers News Contact Us Cardiac medical devices and components Home / Medical Markets / Cardiac rhythm devices 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” GET THE WHITEPAPER 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! 501 County Road E2 Extension New Brighton, MN 55112 Phone: +1-651-633-4200 Fax: +1-651-633-5486 ©2021 Donatelle. All rights reserved. Donatelle and the Donatelle logo are registered trademarks of Donatelle Plastics Incorporated. | Privacy Policy