1. About CIRTEC

CIRTEC Medical Systems has decades of experience helping our clients to develop and manufacture Novel medical devices for the Cardiovascular, Neurological, Gastrointestinal, Orthopedic, and Diagnostic Instrumentation sectors. Customers turn to us to develop solutions for minimally invasive systems, active & passive implants and electro-mechanical systems. Our insights, breadth of capabilities and capacity take your projects from concept through clinical trials to volume manufacturing, and everything in between. CIRTEC will address your needs, meet your challenges, and execute your ideas on plan and on budget the first time around.

CIRTEC Medical Systems combines the strength of Circle Medical’s extensive design and development capability with Texcel Medical's exceptional development and manufacturing. The strategic union creates a strong, technically-driven, 130-person full-service medical device engineering and manufacturing industry resource that is deeply-experienced across all therapeutic categories.

The company’s work has resulted in successful FDA 510(k), PMA and CE submissions for numerous medical device projects

2. Locations:

With locations on the East Coast, in the Midwest, and on the West Coast, CIRTEC has a facility close to your project team.

West Coast
CIRTEC’s West Coast facility includes full Medical Device engineering and contract manufacturing located in a 28,000 square foot facility in Los Gatos, California.

East Coast
CIRTEC’s East Coast facility includes full Medical Device engineering and contract manufacturing located in a 20,000 square foot facility in East Longmeadow, Massachusetts

Midwest
Coming Soon - CIRTEC’s expanded Midwest facility in Minneapolis Minnesota

3. Quality:

CIRTEC is ISO 13485-2003 Certified and FDA Registered.

4. Capabilities:

i. Engineering Solutions:

a. Mechanical Engineering Solutions

b. Electrical Engineering Solutions

• Analog/Digital/RF engineering
• Motion Control Systems
• Temperature Measurement and Control
• Microprocessor Design and Control
• Versed in North American & EU Safety Standards
• UL60601/IEC 60601-1-1
• Electical Safety Testing / Consulting
  CIRTEC can provide consulting services for evaluating and/or creating designs for conformance with appropriate North American and International standards. We have experience with Electrical Safety Standards, Software Standards, and EMC standards related to marketing in the USA, Canada, and Europe. These include:
  • IEC 60601-1-1; Electrical Safety for Medical Devices.
  • IEC 60601-1-2; European Standard for Electro Magnetic Compatibility
  • UL 2601-1 (UL 60601-1); North American Safety for Medical Devices
  • IEC 60601-1-4; European Standard for Programmable Medical Devices.
  • AAMI HF18, Electrosurgical Units
  • Many of the particular standards related to EKG's, Microwave Medical Devices, Device Cabling, and others.
• Software Engineering Solutions
  • Embedded Real-Time Software for machine/instrument control
  • PC based Software (C and C++) for medical systems.
  • Test Systems for Research & Production
  • Digital Signal Processing (DSP) Design

C. Industrial Design

CIRTEC integrates Industrial Design (ID) and Human Factors Engineering (HFE) into the product development process to substantially enhance the effectiveness, safety, and desirability of medical devices. Our industrial design service works to combine functional engineering along with other crucial aspects that address end-user and patient needs. These needs include the human factors of ergonomics and interface designs which provide enhanced usability, reduced fatigue, and greater safety. Increasing the expedience and accuracy of medical devices results in reduced user errors, decreased procedural times, and thereby increased profits as a natural outcome. Well executed industrial design also leads to devices that are pleasing to hold, to use, and even to look at.

D. Packaging:

CIRTEC provides complete packaging and labeling design & development solutions for a variety of applications including minimally invasive surgical devices, implantable devices, accessories kits, and manuals for its customers. We develop and support packaging requirements.

E. Materials Analysis:

CIRTEC has a full in-house metallography lab for preparing surfaces for analysis by grinding, polishing, and etching to reveal micro-structural constituents. After preparation, the samples are analyzed using optical or electron microscopy. Our highly trained technicians are able to identify alloys and predict material properties, as well as processing conditions

F. Chemistry:

CIRTEC provides product development, analytical chemistry and regulatory consultancy for the development and registration of drug delivery, combination devices, and biological products. Our staff is experienced in all aspects of R&D, Quality, and FDA and ISO regulations required to obtain successful regulatory approvals for these products.

ii. Development & Prototyping

CIRTEC Medical Systems is your single source partner for a seamless transfer of technology from design and development into prototype builds and full scale manufacturing. Our collaborative product development teams work closely with you to ensure early consideration of design for manufacturing and assembly (DFMA) for decreased production cost and fast time to market. In-house machining and tooling capabilities allow rapid prototyping and quick turns of early design iterations. Engineering and manufacturing teams work closely to ensure smooth Design Transfer and production documentation, training and facilities necessary for pilot and full scale manufacturing.

A. Design Transfer

• Collaborative Design Teams
• Design for Manufacturing and Assembly (DFMA)
• Scalable Pilot Manufacturing
• Design Verification
• Process Validation

B. Prototype Builds

• 3D Modelling
• CNC Machining
• Industrial Design Foam Models
• Rapid Prototyping Capability
• Electrical Engineering Lab

iii. Manufacturing Services

CIRTEC employs laser welding for critical welding and marking operations and has expertise in various grades of stainless steel and titanium, as well as most other metals. In addition, we process a wide range of polymers and adhesives for applications including machining and joining of molded and extruded parts, cyanoacrylates, medical-grade adhesives, epoxies, silicones and coatings. Our systems are fully ISO 13485 certified and qualified to support our client's overall production requirements.

• Hermetic assembly: Laser marking, electrical assembly, vacuum baking, hermetic welding
• Minimally Invasive Device assembly
• Electromechanical Systems assembly
• Coil winding, wire stripping, crimping
• Silicone coating, backfilling, adhesion
• Cleaning
• Packaging and Labeling