Category: Quality Management

5 Questions to Evaluate your Records v. Documents Management Practices

Documents, documents everywhere.  But which are the records, which are documents—what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation.  In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA Q-Subs,...
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Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-UpQuestionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your documentchanges...
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Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to...
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Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly...
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21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What...
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How to Structure a Medical Device Company

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....
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Life Science Cloud Vendor Selection

Life Science Cloud Vendor Selection Part 2

Technology Strategies to Ensure Benefits and Mitigate Risk Options to Discuss with your Life Science Cloud Vendor Cloud computing is defined to have several deployment models, each of which provides distinct trade-offs which are migrating applications to a cloud environment. NIST defines the cloud deployment models as follows: Private cloud: The cloud infrastructure is operated...
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