Contract R&D Services for Medical Devices

Contract R&D Services for Medical Devices

As a contract R&D, design, engineering and manufacturing services provider to a wide range of clients in the medial/life sciences industry, D&K Engineering offers the following services to medical/life science organizations:

New product development;

Medical electronics and technology enrichment;

Product lifecycle management;

Risk Management per ISO-14971;

3rd party agency testing;

Certification Services (IEC60601-1 3rd edition, IEC61010-1,
IEC61010-2-101, EMC Testing [e.g. EN60601-1-2:2007 /
61326-2-6, IEC61326-1 / 61000-3-2 / 61000-3-3], ISTA2 and
ASTM D4169.09);

Software development;

Post market engineering support; and,

Finished Device Manufacturing.


D&K Engineering’s dedicated medical R&D, design and manufacturing facility is FDA registered and our NPI and volume contract manufacturing facilities in San Diego and Singapore are ISO-13485 (Medical Devices) certified.

D&K Engineering has experience in design, development and manufacturing for medical devices and equipment such as:

Home medical devices and systems

Disease detection and diagnostic systems

Surgical instruments, such as:
Chest tube cutters for trocar insertion
Bovie knife (RF cutter) accessories
Medical lasers and equipment for surgery
Mechanical design concepts and feasibility studies for
ophthalmic surgical devices; as well as:

Patient care and therapeutic devices

Biomedical research instruments; and, a range of other medical design, R&D and manufacturing work.