ABOUT PTI ENGINEERED PLASTICS

PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies. PTI is a diverse company servicing the medical, automotive, defense/aerospace, and commercial/consumer products industries. From low to high volume, simple to complex, prototype to production, PTI delivers quality end products. Our 155,000 square foot advanced manufacturing facility offers 4,000 square feet of ISO Class 8 Cleanroom and 5,000 square feet of controlled environment with both areas offering assembly and packaging services. PTI offers an array of value-added services and is fully versed in IQ/OQ/PQ validation protocol, and Production Part Approval Process (PPAP).

PTI Engineered Plastics History

PTI is a privately held company, founded in 1984, which operated under the name of Proto-Tech Industries until 1987. Proto-Tech Industries produced functional prototype molds and injection molded samples before changing our name to PTI Engineered Plastics. The name change was driven to better reflect the turnkey, mind to manufacturing operations that PTI is today. In 2011, PTI expanded its design capabilities with the launch of PTI Design, an in-house design studio that specializes in product innovation and development.

Reliable medical equipment can often spell life or death, and we take that responsibility very seriously.

PTI Engineered Plastics provides medical device manufacturers with full-service advanced product development delivered in a compressed timeframe. With superior design, tooling, and molding capabilities, PTI turns product visions into reality and gets your product to market first.

We have been serving the medical industry for more than 30 years, specializing in handling complex, multi-part programs and medical device molding for a variety of customers. Our direct contact with doctors and other medical professionals gives us insight into their needs and helps define and assist with final product solutions.

Capabilities include:

  • Medical Device Design
  • Medical Device Molding
  • Cleanroom Molding and Assembly, Class 8
  • ISO 13485 Registered and Compliant
  • FDA Registered
  • RJG Certified Mold Builder and Tryout Facility
  • Cavity Pressure Sensing and Scientific Injection Molding


   Injection Molding            Industrial Design           In-House Tooling            Prototyping

Quality Certifications

Standard or Requirement Status Certificate Issue Date
ISO9001:2008
(General)
Certified C0104779-IS2 12/18/2015
ISO13485:2003
(Medical)
Certified C0104779-MD2 12/18/2015
ISOTS16949:2009
(Automotive)
Certified C0104779-TS3 11/23/2015
FDA Registered
(Medical Device)
Registered 3007238674 11/19/2008
21CFR Part 820
(Health & Human Services)
Compliant   10/17/2008
22CFR Part 120-122
(International Traffic in Arms Regulations)
Certified M24593 3/31/2009
MIL-STD-1916
(Military Test Method Standards)
Compliant   09/18/2008
IMDS/Reach/RoHS
(Intl. Material Data Systems,
Restricted or Hazardous Substances)
Registered 24072 10/10/2008
Underwriters Laboratories
(Product Testing Certification - D1103)
Certified 754319-001 12/30/2008

 

CONTACT INFORMATION

PTI Engineered Plastics, Inc.

50900 Corporate Dr.

Macomb, MI 48044

UNITED STATES

Phone: 586.263.5100

Fax: 586.263.6680

Contact: Cheryl Kaiser