Medical Device Product Development

Cirtec Medical Systems delivers a full range of expertise and services for medical device product development.

Mechanical Engineering

Cirtec Medical Systems engineers have extensive experience designing the complex mechanisms for medical devices that meet the requirements of our robust quality system and design controls. Cirtec’s mechanical engineering team leads the field in providing elegant and cost effective medical device design and development services for your mechanical design challenges, specializing in complex medical device development including:

  • Cochlear Implants
  • Stents, grafts and valves
  • Neurostimulators and Neuromodulators
  • Implantable and External Pump applications
  • Implantable Cardiac Defibrillators and pacemakers
  • Articulating, rotating minimally invasive surgical tools
  • Multilumen and articulating Catheters and Delivery Systems
Electrical Engineering

Cirtec’s electrical engineering team has a solid track record in developing innovative solutions for device applications. Cirtec focuses on optimizing medical device designs for electrical performance, cost, and safety. All medical device electronics must meet rigid electrical safety requirements. Cirtec’s electrical engineers are experts in medical device design and medical device product development. We can provide consulting services for evaluating and/or creating designs for conformance with all latest North American and International standards including:

  • IEC 60601-1-1; Electrical Safety for Medical Devices.
  • IEC 60601-1-2; European Standard for Electro Magnetic Compatibility
  • IEC 60601-1-4; European Standard for Programmable Medical Devices.
  • UL 2601-1 (UL 60601-1); North American Safety for Medical Devices
  • AAMI HF18, Electrosurgical Units
  • Standards related to EKG’s, Microwave Medical Devices, and Device Cabling.
  • Analog/Digital/RF engineering
  • RFID for device/disposable identification
  • Implantable Pulse generators
  • Telemetry
  • Transcutaneous charging systems
  • Electro-optical systems
  • Wireless communication
  • Electro-surgical tools for ablating, cauterizing and cutting applications
  • High gain, low noise amplifiers for measurement of patient and device parameters
  • ECGs
  • Motion Control Systems (Stepper, Servo, Actuators)
  • Microprocessor Design and Control
Software Development

Cirtec’s software engineering team is experienced in the development and test of embedded software systems. Our team has a specialty in development of software applications for active implantable devices, including nerve stimulators and blood pumps. Cirtec’s team also employs state-of-the art medical device product development tools for rapid production and accurate traceability. The software team is intimately familiar with the following standards and guidelines for software development:

  • IEC 62304:2006: Medical Device Software – Software Life Cycle Processes
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,
  • General Principles for Software Validation; Final Guidance for Industry and FDA Staff
  • FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices
  • Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Human Factors Engineering & Industrial Design

Cirtec integrates Industrial Design (ID) and Human Factors Engineering (HFE) directly into the medical device product development process. Our ID team works to combine functional engineering with the other crucial aspects that address end-user and patient needs. Effective HFE leads to improved usability, reduced fatigue, and enhanced intuitive control. This means fewer user errors and shortened procedural timelines. The logical outcome ensures a device that is not only safe to use but also leads to increased profitability. A safe and usable medical device needs one more attribute for user acceptance – user appeal. Our engineers apply their sense of aesthetics to every element of the design to ensure that users will also find the device to be appealing.

Cirtec’s ID & HFE services include:

  • Concept Development and Illustrations
  • Graphical User Interface (GUI) design and development
  • Photorealistic Renderings and Animations
  • Advanced Surfacing (Solidworks, Pro-e, Alias, Rhino)
  • Foam and in-house rapid prototyping services
  • Human Factors Task Analyses
  • Anthropometric Research
  • Heuristic Reviews
  • User Interviews and Focus Groups
  • Formative and Summative Usability Studies
Design Verification & Validation

Whether you are seeking a PMA or 510k under CDRH or a combination device through CDER, Cirtec will help you through the hurdles that hinder many medical device manufacturers. When it comes to material qualifications, sterilization processing, biocompatibility testing, or CMC filing, Cirtec has it covered. Cirtec offers these following services:

  • Sterilization process development (ETO, Gamma, autoclave, e-beam)
  • Special ETO process development (low temperature, RT)
  • Development of process challenging devices
  • Medical-grade material qualifications
  • Cleaning validation using various assays (TOC, GC-MS, etc.)
  • Management of biocompatibility testing and sterilization validation
  • Analytical method development, validation, and quality control testing
  • Preparation of the Chemistry, Manufacturing, and Controls (CMC) section for drug and combination device filings