Testing and Inspection
Analyze This: Device Cleanliness Testing
A scientist weighs a crucible for gravimetric analysis. Most medical device manufacturers know the importance of putting a product through rigorous cleaning and testing before it is released into the market. Standard sterility and biocompatibility tests are an essential...
Get with the Program
FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs.1   During the packaging validation process, one of...
No Dirty Devices Allowed
Many device design engineers and manufacturers do not realize the significant role that cleaning and coating methods can play in the consistency and quality of device performance once it’s in a doctor’s hands. Although it is sometimes an afterthought, cleaning and...
A New Perspective on Medical Device Certification
In this proposed certification model, early collaboration can help manufacturers stay on track with standards requirements. The third edition of IEC 60601-1 will soon become de facto mandatory for certification of medical devices. This standard is unique, combining both...
Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 2
According to FDA regulations, certain medical devices need to be evaluated for biocompatibility. As a start, manufacturers may search FDA’s Web site to see what comes up on the topic of biocompatibility testing. Many search results will include references to documents such as...
Clinical Evaluation Reports: The New Requirement
Changes are sweeping European medical device regulations, and they will affect every company that markets devices in Europe. A 2007 amendment to the Medical Devices Directive (MDD) 93/42/EEC will come into force in March 2010. The bottom line of the amendment is that every medical...
Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 1
Suddenly you find yourself responsible for having a medical device evaluated for biocompatibility. What does this mean and how do you go about it? As a start, perhaps you search the FDA Web site for the topic of biocompatibility testing. You may find yourself on pages discussing...
Reducing Defects: Visual Inspection of Medical Parts
  PART INSPECTION       Borescopic visual inspection may be appropriate for small parts with areas not visible to the naked eye. Even with all the high-tech testing and inspection techniques in use today, basic visual inspection of medical device...
Leak Detection: A New Method for Medical Electronics
  TESTING       The need for reliability in implantable medical electronic devices is paramount. Quite often, a patient's health depends on the integrity and reliability of an implanted medical electronic device. Body fluids are ionic in nature, corrosive, and...
Nanostrings on Pitch for Measuring Viruses
R&D DIGEST Kamil Ekinci and Todd Murray of Boston University believe that a nanostring and laser apparatus can help measure and identify viruses and other biomolecules. The system operates using the same principles as string-based musical instruments....