Medical Device Manufacturers
RKM Corporation
34 Executive Dr Ste 1, Danbury, CT 06810, United States
- Contract manufacturer / job shop
- Founded 1978
- ISO 13485:2016
About RKM Corporation
RK Manufacturing operates from a 65,000-square-foot facility in Danbury, Connecticut. The company was founded in 1978 by Ron Krebs to serve the equipment needs of suture manufacturers worldwide. Today it is owned and operated by Donna Krebs. The business runs two operational groups: medical device contract manufacturing with clean room assembly, and machine tool development and manufacture. Its 15,000-square-foot ISO Class 8 clean room supports assembly, packaging, and testing of sutures, ferrules, bone screws, spinal implants, and robotic surgery accessories. Machining services include prototyping, tooling, and fixture design and fabrication. Custom winding and attaching machines are built for specialty suture applications. There is no minimum order requirement, and warehousing is available. Customers span surgical disciplines and include original equipment manufacturers seeking design, development, and production of sterile and non-sterile medical devices. The company's scope covers suture manufacturers as well as producers of orthopedic implants and robotic surgery components. RK Manufacturing emphasizes a "your products are our products" philosophy, backed by ISO 13485:2016 certification with no exclusions and FDA registration. A risk-based quality management system compliant with 21 CFR Part 820 governs all processes, and certified sub-contractors handle sterilization to operating-room standards. Flexible manufacturing allows quick, cost-efficient runs for both large and small quantities.
Manufacturing capabilities
Inspection & quality
Assembly & services
Industries served
- Medical device manufacturing
- Surgical instruments
- Orthopedic implants
- Robotic surgery
- Suture manufacturing
Equipment
- Custom winders
- Attaching machines
- Suture manufacturing equipment
- ISO Class 8 clean room (15,000 sq. ft.)
- Environmental control systems
Company details
- Location
- Danbury, Connecticut
- Company type
- Contract manufacturer / job shop
- Founded
- 1978
- Minimum order
- No minimum order requirement
- Production volume
- Prototype to full commercialization; no minimum order
- Certifications
- ISO 13485:2016
- Listed under
Frequently asked questions
Where is RKM Corporation located?
RKM Corporation is located at 34 Executive Dr Ste 1, Danbury, CT 06810, United States.
What does RKM Corporation do?
RKM Corporation is listed under Medical Device Manufacturers, and its listed capabilities and products include Medical device contract manufacturing, Clean room assembly (ISO Class 8), Machine shop services (CNC machining, prototyping, tooling, fixture design & fabrication), Custom machinery design and manufacture (winding machines, attaching machines), Suture manufacturing equipment fabrication and Needle material and configuration supply.
What industries does RKM Corporation serve?
RKM Corporation lists Medical device manufacturing, Surgical instruments, Orthopedic implants, Robotic surgery and Suture manufacturing among the industries it serves.
What certifications does RKM Corporation have?
Certifications on file for RKM Corporation: ISO 13485:2016.
When was RKM Corporation founded?
RKM Corporation was founded in 1978.
How do I request a quote from RKM Corporation?
Use the Request a quote button on this page to send RKM Corporation your requirements through FirmsLedger, or call (203) 797-8700 and visit rkmcorp.com.
What companies are similar to RKM Corporation?
Other Medical Device Manufacturers in Connecticut listed on FirmsLedger include Medzah Industries, Bio-Med Devices, Inc. and Putnam Medical Corporation.