Quality Management System - Methodsense, Inc

March 27, 2019
By Russ King
QMS, Quality Management, Risk 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,...

March 14, 2019
By Russ King
QMS, Quality Management

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...

March 5, 2015
By Rita King
FDA 21 CFR Part 820, Quality Management, Risk Management

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...

February 12, 2015
By Rita King
FDA 21 CFR Part 820, FDA Compliance, Quality Management

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...

Tag: Quality Management System

5 Questions to Evaluate your Records v. Documents Management Practices

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Implement 21 CFR Part 820 Controls Early On

21 CFR Part 820 Ensures Your Device is Safe and Effective