Featured Articles
-
Compliance Tips For New Medical Device Products
9/30/2021
How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.
-
Identifying And Preventing Common Data Integrity Issues
9/30/2021
Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate. A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.
-
Digitization In Medical Device Manufacturing: 4 Priorities
9/14/2021
Over the past year and a half, the global business disruption has created a sense of urgency around accelerating efforts to digitize and connect offline or siloed areas of operations. Most manufacturers see the benefits of digital transformation, but many don’t see the roadmap. Here are a few ways to apply digitization to enable agility and improve operations.
-
Supplier Quality Agreements 101: What, Who, And Why?
9/14/2021
Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.
-
How A Platform Approach To Technology Modernization Is Transforming Manufacturing Performance And Quality
8/31/2021
A provider of digital X-ray products and X-ray films with more than 4,400 employees in globally distributed locations was focused on updating their legacy systems. Read how a flexible solution has allowed them to deploy fewer, more modern technology tools across their global manufacturing environment with a single platform for production and quality management, which has resulted in improved visibility, efficiency, productivity and risk mitigation.
-
Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments
8/31/2021
By understanding the FDA’s updated approach to medical device regulation and the information provided in the inspection observations document, medical device companies can more easily identify and mitigate compliance issues.
-
ISO 13485 - Change? Do I Have To??
8/31/2021
Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier.
-
Quality System Metrics That Matter
8/27/2021
Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.
-
Metrics That Matter For Contract Manufacturing
8/27/2021
For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.
-
What's The Difference When It Comes To Managing Quality?
8/27/2021
QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.