Choosing a Contract Manufacturer for Your Medical Device

Physicians, nurses and other healthcare professionals and patients greatly rely on technology every day to diagnose and treat individuals. Since these products play a crucial role in patient care and because of the severity of the consequences in introducing unsafe or hazardous products, manufacturers are held to the highest standards. Choosing the right medical device contract manufacturer is one of the most important decisions companies make, and it can be challenging due to the many considerations to keep in mind. You want a precision medical device manufacturer that brings your medical product to the market successfully and in compliance with industry standards.

Experienced Precision Manufacturing Professionals

Medical device manufacturing requires experienced and highly skilled professional who have a talent and interest in precision machining. They must possess a strong understanding of accuracy for even the smallest of parts since they can be life altering.

Ensured Quality Every Time

Any product manufactured should always meet the expectations of customers. As a leading manufacturer, we guarantee that our medical device products will exceed your expectations. We use a custom anodizing process for aluminum and titanium metals in order to prevent corrosion and improve performance and expand the life of the product. We monitor the manufacturing process to ensure that high quality is met every time with the use of machines and expert engineers.

FDA Compliant

Manufacturers must follow and meet production standards and regulations for producing medical devices. At MK Precision, we ensure that our facility is 100% compliant with these standards. We are registered with the Food and Drug Administration (FDA) as our medical devices are intended for commercial distribution. We are also registered with the International Traffic in Arms Regulations (ITAR) since we also serve the aerospace industry. Additionally, we have two certifications from the International Organization for Standardization (ISO) which include the ISO 13485 and ISO 9001:2008. The ISO 13485 indicates the requirements for a quality management systems used to design and manufacture medical devices. The ISO 9001:2008 specifies that MK Precision is involved in the creation of new products and requires that manufacturer developed products have an approval process.

Medical Devices MK Precision Manufactures

As a prominent manufacturer, we manufacture a number of implants, including:

  • PEEK Implants –Spinal implants, lumbar implants, and thoracic implants as well as PEEK spacers and screws.
  • Dental Implants – Endosseous implants, subperiosteal implants or transosteal implants.
  • Orthopedic Devices – Custom designed spinal implants, expandable cages, bone screws, bone plates and others.
  • Bone and Surgical Screws

At MK Precision we are committed to producing and delivering the only the highest quality products for our clients. To learn more about our products and/or company visit our website or contact us today.