Medical Device Development
A partial FDA definition for a medical device is, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” From this definition it is evident that a medical device can cover a wide variety of uses and applications. Medical device development means not only engineering a device that is physically and chemically sound but also navigating the complex regulatory hurdles put in place to keep people safe.
Medical Device Testing at EKG Labs
EKG Labs is an industry expert in providing medical device development support services. We provide a variety of services to support 510(k) and PMA filings. One of our specialties is providing analytical services that support the development of medical devices that are implanted or come into contact with the human body. EKG also has extensive experience in drug device testing (combination product testing). We provide services that help our clients answer questions like:
- What is the extractables and leachables profile of my implantable device?
- Does the manufacturing process of my device impact its biocompatibility?
- Are there elemental impurities in my device?
- What is the identity of this unknown impurity and should it be investigated further?
- What tests and regulatory data do I need to submit my device for regulatory approval?
- Does my polymer dissolve at the appropriate rate?
- What are the device performance characteristics of my product?
- Is my pump delivering medication at the appropriate rate?
Our medical device testing services include:
- Extractables and Leachables
- Impurity Identification
- ISO 10993 Biocompatibility
- Specialty Devices
- Device Materials
EKG Labs Medical Device Testing Expertise
- Intraocular Lenses
- Drug-Eluting Stents
- Orthopedic Devices
- Dental Implants
- Cardiac Devices
- Dermal Wound Care
- Diabetic Devices
- Vascular Devices
- Read some EKG Labs case studies here or learn more about our medical device product expertise.
EKG Labs Material Expertise
We have experience providing services for diverse materials in a variety of medical device products. These materials include:
- Composite Materials
Learn more about our material expertise.