MethodSense Re-Launches LuminLogic Website
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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.…
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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-Up Questionnaire: If you answered, without hesitation, “Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think…
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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…
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eSTAR Submissions, a New Method for US FDA Medical Device Submissions
Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive…
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Ensuring Compliance Success: Quality & Regulatory Management with Expert Support
Quality & Regulatory Management Software Having a quality and regulatory management software solution designed specifically for life science and regulated companies helps keep business processes running smoothly and in compliance. Every year, every month, even every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality Management System. When…