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Home » Topics » Devices » Quality

Quality
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Expert Insights on Process Validation for Devicemakers

April 28, 2023
The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Read More

Why You Need a Quality Agreement With Suppliers

August 17, 2022
Although a quality agreement is not specifically required or defined in FDA regulations, the FDA may ask during an inspection to review any documents that describe the way you manage contract service providers. Read More

Hazard Analysis Key in Risk Management for Combo Products

September 14, 2020
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More

Hazard Analysis Key in Risk Management for Combo Products

September 11, 2020
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More

Russia Implements New Quality Control Requirements

September 16, 2019
Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Read More

NEMA Issues New QMS Standard for Servicing Imaging Equipment

May 3, 2019
The National Electrical Manufacturers Association (NEMA) released a new quality management standard for servicing medical imaging equipment—designed to ensure equipment is returned to a safe and effective condition for its intended use. Read More

FDA Releases Guidance on Quality Considerations for Inhalers

May 15, 2018
The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes. Read More

NSF Names Medical Device Certification Director

April 13, 2018
Serpa carried out the assessments of six of the 14 Auditing Organizations currently authorized to perform MDSAP certifications. Read More
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Medical Laser Manufacturer Draws Lengthy FDA Warning

February 6, 2018
At least three complaint cases evaluated by the FDA lacked the required root cause investigations or rationale for not initiating investigations. Read More

CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

January 19, 2018
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More

Warning Letter Roundup: FDA Warns Devicemakers in India, Lithuania, Texas

January 18, 2018
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More

CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

January 18, 2018
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
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