Join us for a discussion on Thursday, March 25th from 12:00-12:45 pm EST
In addition to all of the typical challenges of building a tech/device startup (e.g., development, marketing, hiring, etc), medical device startups need to adhere to regulatory and quality endpoints. While a variety of factors come into play, there are four phases that can help you build a quality roadmap.
We're delighted to have Melita Ball host our March 25th Quality Leaders Forum to discuss her experience building quality roadmaps with medical device startups and her 4 Phase framework.
Our Forum Leader
Melita Ball is a Regulatory & Quality Systems professional with 28 years' experience in Life Sciences. She is the CEO and Principal Consultant at MBC & Affiliates, Inc. (MBCA). She has particular expertise in establishing compliant quality systems and leading large and small teams on remediation projects.
Melita is considered an expert in global regulatory compliance requirements including: ISO 13485:2016, ISO 14971:2012, PMDA MO 169, BGMP 16/2013, TGA Therapeutic Goods (Medical Device) Regulations 2002, EU 2017/745 (New MDR), 21 CFR Parts 11, 801, 803, 806, 809, 810, 820, and MDSAP.
Melita is experienced in establishing and leading consulting teams through large projects to achieve successful outcomes for her clients.
P.S. Because our forum is discussion-based, we don't record the session. Let us know if you're unable to make it, but would like the follow-up materials.