Habit 2 Mindset is a Quality and Regulatory consulting company in the medical device space.
Our mission is to help medical device companies accomplish their goals.
Habit 2 Mindset comes from “Habit #2: Begin with the end in mind” which is a principle from Stephen Covey’s book, The 7 Habits of Highly Effective People. The general principle of this habit is taking the mental idea of the end goal and creating physical actions to achieve the result.
You are a start-up and are looking for someone to help you create an effective and efficient system that is the right size for your company based on where you are now, how you want to grow, your type of product, and meet regulatory compliance. We can help you get on the right track.
Standards, guidance, and regulations are always being updated. This puts a wrench into your plan and now you’re wondering how to meet the updates. You would need to create a gap assessment and then implement the change within your organization. If you didn’t plan for this, we can take this task off your hands.
You have identified an ineffective or inefficient process and you need help to find a solution to reduce or eliminate this problem. You lack resources within your organization to attack this problem and so you need support. Let’s make the system work for your product and employees. We can help make your employees happy with a better process, which in turn will improve your product quality.
Need to meet regulatory compliance with an internal audit? Or need someone to help you identify potholes? We can be your independent auditor.
Design control includes planning, requirements, risk management, standard testing, product verification and validation, design reviews, and design transfer. Are you ready to get your product into design control? Do you need a quality partner to help you through the process? We can help you as little or as much as you need. Design Control is our specialty.
Thinking of submitting your product to the FDA for review? Let’s work on the strategy and create a big book for the FDA to understand that your product is safe and effective and it deserves to be on the market.
We have tested many products as quality engineers. We enjoy learning about the product via this hands-on exercise. We can help you find bugs.
Tell me what you’re working on and I’ll tell you how I can help.