Medical Device Contract Manufacturing — RK Manufacturing Corporation

RK has two operational groups: Medical Device Contract Manufacturingand Machine Tool Development and Manufacture. We have the knowledge and experience to take your product / design from inception to final packaging. Our certified quality inspectors monitor every process, so you can be sure your product will be defect free. We have the capability and capacity to assist you in completing all of your assembly needs.

At RK Manufacturing, we pride ourselves on having the best customer service in the industry. Our knowledgeable staff is always ready to assist you. Quick response time and attention to quality make us an invaluable supplier to our customers. Our flexible manufacturing capabilities allow us to produce large and small quantities quickly and cost efficiently.

The Medical Device Contract Manufacturing Group offers:

• Design and Development Assistance
• Prototyping
• Custom Manufacturing
• Short lead times
• Orders sizes from 1 to 1,000,000
• Complete suture and medical device assembly
• Clean room/White room environments
• Final sterilization of packaged product
• Full lot control and traceability
• Sterilization validation and processing
• Validation protocol development, testing and reports
• Complete work order history
• Worldwide shipping

The Machine Tool Development and Manufacturing Group offers:

• Tooling, fixture design and fabrication
• Prototyping
• Precision machined suture processing equipment
• Comprehensive Machining services
• Worldwide shipping

---

Originally published at rkmcorp.com.

RKM Products -Medical device contract manufacturing

As a contract manufacturer RK Manufacturing produces customer’s products to their design specifications. Non Disclosure Agreement’s typically govern the information that can be shared with potential customers. RKM currently manufactures, assembles, and packages specialty sutures. The current sutures range in size from #7–0 to #5 and are assembled with many of the standard suture materials in the market and several proprietary ones. The suture materials are either monofilament or braided configurations. The sutures are either individually packaged or loaded in bulk.

RK also assembles devices that contain surgical screws and ferrules.

---

Originally published at rkmcorp.com.

Medical device contract manufacturing- RKMCorp

As a contract manufacturer RK Manufacturing produces customer’s products to their design specifications. Non Disclosure Agreement’s typically govern the information that can be shared with potential customers. RKM currently manufactures, assembles, and packages specialty sutures. The current sutures range in size from #7–0 to #5 and are assembled with many of the standard suture materials in the market and several proprietary ones. The suture materials are either monofilament or braided configurations. The sutures are either individually packaged or loaded in bulk.

RK also assembles devices that contain surgical screws and ferrules.

Read more- Medical Manufacturing Companies
Medical device manufacturing

Contract Manufacturing — RK Manufacturing (Medical device contract manufacturing)

We offer full machine shop services to our customers, including custom made fixtures, tooling, dies and equipment, to help transform your ideas into finished product.

Our machine shop services include:

• CNC milling and turning for machined components
• Precision custom tooling
• Separate final packing rooms
• Prototype machining services
• Heat treating, grinding, welding and assembly
• Design assistance
• In-house tool and die

RK is capable of contracting to produce medical devices that require manufacture, assembly, testing, and packaging in a clean room environment. We have certified sterilization sub-contractors to bring your product to operating room levels of sterilization. Our Quality Management System has been certified to ISO 9001 and ISO 13485 to assure you of quality products made by Current Good Manufacturing Practices (CGMP).

Read more- Medical Manufacturing Companies
Medical device manufacturing

---

Originally published at rkmcorp.com.

Figure 8 Winder - RK Manufacturing Medical Manufacturing Companies

The Automatic Figure 8 Winder is used to wind the suture into the suture card in a figure 8 shape for easy dispensing.

The suture card is placed into the nest, with left hand. The un-needled end of the suture is placed between the feed rolls using the thumb and forefinger of the right hand and is fed automatically into the suture card forming a figure 8 shape. The needle will stop once it reaches your fingers. The needle is then slid out of the feed rolls and inserted into the suture card.

Notes:

• The feed rolls feed the suture into the suture card using very little tension, so not to damage the suture material or cause injury to fingers by needle.

Read more-Medical device contract manufacturing
Medical device manufacturing

---

Originally published at rkmcorp.com.

Medical device contract manufacturing (Rack Winder) - RK Manufacturing

An easy way to prepare braided suture material
The RK Rack Winder is used to prepare braided suture material for needle attaching. The suture ends are tipped (stiffened) so they can be easily inserted into the needles and sutures are cut to their required length.

Size: 48″ wide x 42″ deep — Workspace: 80″ x 80″ — Yield: 2,000/hour

The braided suture material is wound from a spool on to a rack, approximately 200 sutures/rack. The circumference of the rack determines suture length. The speed of the rack is adjustable, at 65 rpm (recommended speed); a rack of 200 sutures would take approximately three minutes.

Read more- Medical device manufacturing

After the rack is wound, it is removed and placed on a table, where a medical grade cyanoacrylate adhesive is applied to a two inch (or as required) portion of the sutures. The adhesive is applied by hand using a small piece of foam and cures in three minutes.
After the adhesive has cured, the suture rack is place into the suture-cutting fixture as shown. The sutures are held in position and cut from the rack using a hand held rotary knife. The sutures are cut through the two inch tipped portion leaving a one inch tipped length at the end of each suture.

Notes:
It is recommended to have three racks for each required suture length. This would allow one rack to be wound, while adhesive is applied to another and sutures are cut from the third rack. Using three racks the operator should yield approximately 2,000 tipped sutures per hour. The racks are not adjustable and are made per your specific suture length requirements.

Read more- Medical Manufacturing Companies
Originally published at rkmcorp.com.

RKM Quality — RK Manufacturing(Medical device contract manufacturing)

Quality Policy

R.K. Manufacturing Corp. is committed to providing quality products and services to the medical device industry that exceeds the expectations and needs of our customers. We are committed to complying with regulatory requirements and maintaining the effectiveness of our quality management system.

Our Mission

R.K. Manufacturing Corporation’s mission is to provide its customers with consistently high quality and to provide a competitive edge to support our customer’s positions in the health care market.

Quality Values and Beliefs

• Outstanding service to our Customers
• Innovation, quality, and value in our products
• Respect for our customers, suppliers, employees and community
• Creativity and teamwork in the workplace
• Honesty and integrity in all that we do

Regulatory

• Registered by BSI for ISO 13485 Medical Device Manufacturing
• Registered by BSI for ISO 9001Quality Management Systems
• FDA Registered Manufacturing facility, Registration number # 1226146
• Compliant with Medical Device Directive (MDD) 2007
• Compliant with 21CFR Part 820, (current Good Manufacturing Practice)

---

Read more- Medical Manufacturing Companies

Originally published at rkmcorp.com.