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Home » Topics » Medical Devices » Quality

Quality
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FDA Launches Device Software Pre-certification Pilot

August 4, 2017
The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More

FDA Warns Ohio Devicemaker Over Validations, Complaint Procedures

July 19, 2017
Investigators found the facility’s complaint procedures did not include evaluating complaints to determine if an investigation was needed. Read More
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What Device Manufacturers Can Learn From FDA’s Inspection Data

July 19, 2017
Companies in China, Germany and the United Kingdom should take heed, as they are the companies most often getting OAIs. Read More

What Device Manufacturers Can Learn From FDA’s Inspection Data

July 17, 2017
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
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What Device Manufacturers Can Learn From FDA’s Inspection Data

July 14, 2017
Companies in China, Germany and the United Kingdom should take heed, as they are the companies most often getting OAIs. Read More

483 Roundup: FDA Cites Firms Over Complaint Handling, Other Deficiencies

July 10, 2017
The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Read More

How to Manage Risk in a World of Changing Design Control Standards

July 10, 2017
How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Read More

MHRA Updates Guidance on UK Notified Bodies

July 7, 2017
In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More

India Changes Acceptance Criteria for IVD Test Kits

June 30, 2017
India’s Ministry of Health and Family Welfare has revised the acceptance criteria for in vitro diagnostic devices to detect HIV, HBsAg and HCV. Read More

Four Devicemakers Cited for Inadequate Procedures

June 30, 2017
The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs. Read More

FDA Cites Four New York Firms Over Procedures, Records

June 27, 2017
The FDA’s observations primarily focused on CAPA issues and record-keeping. Read More
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FDA Hits Kronner Over Complaints, Reporting Procedures

June 27, 2017
The company failed to document verification or validation of corrective actions taken in response to two complaints. Read More
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