Historically, IVDs have been treated as low-risk medical devices on the grounds that physicians do not rely on a single piece of information when making diagnoses or treating patients. However, this...
Reducing Recalls Possible with Risk Assessment Tool A new risk management program could help sterile medical packagers cut down on recalls, said industry consultant Hal Miller. Miller, president of...
Medical Device & Diagnostic Industry Making a risk management program part of a company's design control procedures satisfies FDA and improves device safety. A study of all voluntary medical...
Manufacturing in the pharmaceutical industry is poised for a quality revolution. As dwindling new product pipelines stall revenue growth at many companies, management is pushing cost containment and...
GUIDE TO OUTSOURCING: GMP COMPLIANCE Many firms are outsourcing the fabrication of devices destined for the U.S. market. Properly managing the current good manufacturing practice (GMP) requirements...