How a Robust QMS Accelerates Reaching Regulatory Milestones
Having a Quality Management System (QMS) in place is key for early-stage companies looking to reach regulatory milestones and increase their value.
Quroba contains a specialized Quality Management System platform that is tailored to meet the unique needs and regulatory requirements of the medical technology industry. The medtech industry is comprised of a wide range of products, including medical devices, in vitro diagnostics, and software applications used in healthcare, that have stringent quality and safety standards that must be met.
Not having access to an efficient and effective QMS to support an early-stage company’s journey to FDA market approval can prevent technologies from meeting regulatory milestones. And, this can negatively impact a company’s implied value with investors.
Quroba can help mitigate that risk by enabling medtech companies to implement QMS.
“One of the biggest levers to do that is to get your marketing approval. To get there, you need a robust QMS. You need someone who's thinking about regulatory, but equally important, you need someone thinking about quality so that you, for example, get proper advice on the right number of samples for a verification test. These are things that quality people understand well and are integrated into rolling out a robust quality management system,” Kwame Ulmer said during a recent Quroba Conversations webinar.
“Being able to meet certain regulatory milestones increases the value of the company. ”
View Full Webinar: Quality Management Systems Overview
Description: In this webinar, we will give you an overview of what it means to have a QMS that is aligned with your engineering (and business) efforts while presenting minimal additional overhead burden to your company. First and foremost, we help you understand what a QMS is and why we have them–and why companies in less regulated industries have used them to maximize quality while minimizing costs. This is followed by an overview of how you can use the policies and procedures within your QMS to add value rather than merely as a compliance exercise. Finally, we talk through how eQMS’ can help you become more efficient and automate tasks that often take a lot of manual wrangling.
About Quroba
Quroba is a technology platform powered by industry experts in regulatory, quality, and compliance to provide business forward solutions helping medtech companies get to market faster.
About Medtech Impact Partners | “Talk to the FDA before you talk to the FDA.”
MedTech Impact Partners is a leader in regulatory strategy and support. Built on decades of government and private sector experience, our services position clients to get innovative health technologies to market faster.
Our team of consultants guide MedTech companies over regulatory hurdles at the FDA, helping them deliver on key milestones and protect their bottom line. MIP’s customized approach and suite of services focus on developing sound regulatory strategy, diligent review, and managing risks for clients.
Need regulatory support? Our team is scheduling discovery meetings to learn more about your organization and goals. If you’re interested in learning more, please contact us.