Some people might call it regulatory compliance or quality programs–but we call it business fundamentals.
Domestic and international regulations are changing faster than ever. You need to manage the commercialization of your product and grow your business. And one mis-step can have grave implications. But MethodSense has the resources to help improve your people, processes and core valuation.
From 510(k) submissions to IEC 60601-1 tables and Software Development Lifecycle Management to Quality System Management, our life science and medical device consultants have the experience to help you bring your product to market without unnecessary delay. Contact us today to learn how we can help you!
We're your business partner
Our experts leave no stone unturned as they solve your immediate need and then turn to ensuring your future success. From the production floor to the board room and beyond—let the MethodSense difference be your competitive advantage.
Latest News and Insights from MethodSense
Accessory or Component and the FDA – The Fine Line Between Them
Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA...
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...
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: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic...
Our goals are your goals: grow your business with the best people, scalable processes and smart technology.
Here are few ways we help our clients:
Regulatory Compliance Consulting
 | FDA submissions, CE marking and risk management consulting |
Quality Assurance
 | Meet FDA 21 CFR Part 820, ISO 13485 quality requirements and more |
Technology Management
 | Achieve 21 CFR Part 11, ISO 62304 and SDLC requirements |