The FDA and other regulatory agencies around the world are tasked with the daunting job of ensuring public health and safety. How do they do this? By making medical device companies comply with their rules and regulations through stacks and stacks of paperwork. Just kidding. But not really. Regulations are constantly changing and as technology grows, so does the amount of documentation and scientific evidence needed to support it. Regulatory agencies love paperwork because…. “If it’s not documented, it didn’t happen.”
WHAT are Quality Assurance and Regulatory Affairs (QA/RA) consultants good for anyways?
Creating paperwork, mostly. We love paper too. But our job is to make sure you have the tools needed to keep these regulatory agencies happy, and above all else, keeping your patients and customers safe. Customers can’t be repeat customers if they die as a result of an unsafe product. But in case you need a detailed list of a few of the services we provide, click below to find out more.
WHY use a consultant?
A better question is, why not? Whether you’re a start-up company who has no idea what you’re doing within the realm of regulatory compliance, or you’re a start-up company who thought you knew what they were doing but turns out you don’t, or you’re an established company just needing a little extra help or guidance, we’re here for you. It’s okay to admit you don’t understand regulations or can’t keep up with all of their changes. We come at an affordable rate and have YEARS of experience. Click below to learn more about the company.
There are several reasons why established companies will outsource activities to a consultant. Many find value in having a “fresh pair of eyes” take a look at their system to identify recurring problems, recommend process flow improvements, and ultimately assist in meeting project and product deadlines and budgets. Consultants work temporarily to help fill the holes within your organization without the need to hire additional personnel.
WHEN should I start thinking about using a consultant?
Yesterday. The earlier you get assistance and knowledge, the better you can plan and the better and faster you’ll get to your goal. Whether it’s getting FDA clearance or approval, CE marking, establishing a robust Quality Management System (QMS), or getting you out of a sticky situation (483’s, Warning Letters, or Consent Decrees), we got your ass(ets) covered.
HOW do I contact you?
Contact info is below. Please don’t hesitate to send an email, even a quick text if you have any questions at all.