Welcome to Manty Medtech.
Providing industry leaders and innovators with motivated, passionate expertise.
Manty Medtech is dedicated to delivering clients quality consulting and professional instruction in strategic product development. With specialized experience in design control, MDR, process development and validation, engineering management and more, Manty Medtech offers trustworthy partnership and direction every step of the way.
I’m Verna Rodriguez.
As founder of Manty Medtech, and Adjunct Lecturer of Bioengineering at Santa Clara University, my driving passion is to share my knowledge from over 40 years of experience in the medical device field with other industry members.
In 2018, I founded Manty Medtech to provide product and organizational development consulting services to industry leaders and emerging companies. I also teach Design Control for Medical Devices in the bioengineering department at Santa Clara University, and provide custom instruction to companies who would benefit from my insight.
My expertise includes design control, root cause analysis, risk management and process validation, with a particular interest in the application of nitinol and its superelastic properties to medical devices.
Find me on LinkedIn:
“Verna is incredibly knowledgeable in her field, experienced and resourceful and always eager to take on a new challenge. She sets the highest standards for her projects and is always prepared. Her analytical skills shine in her ability to hone in to the heart of any question- whether from a legal or technical standpoint- and truly add value to the conversation.”
— Ariadni Couri, Patent Counsel, BAT
Features
The New EU MDR and What It Means for Medical Devices
Xtalks • October 31, 2019
The recent transition from the European Medical Device Directives (MDD 93/42/EC and MDD 90/385/EEC) to the new European Medical Device Regulations (EU MDR 2017/745) brought several highly impactful changes, noteworthy whether you are a small or large medical device developer, manufacturer, supplier, contract research organization (CRO), or notified body. In this webinar I cover:
Why and how the new EU MDR regulations came about
How to take appropriate steps to ensure you’re prepared
About EU MDR’s emphasis on clinical evaluations and investigations – and why this matters
Why EU MDR necessitates eClinical platforms that boost efficiency, accuracy and compliance
Reducing Medical Device Product Risk: The Key Role of Clinical Trial Data in Product Development
Xtalks • April 23, 2019
In this webinar I discuss the importance of thorough, accurate and timely reporting of adverse events from feasibility studies through post-market clinical trials, as well as how medical device development teams can follow best practices in using the information in product risk management. Additionally, I provide insight into the connectivity between product risk management (ISO 14971) and the clinical risk management process (ISO 14155) and the use of eClinical platforms in supporting this process.
Thought Leader Spotlight: Verna Manty Rodriguez on MDR and the Future of the Medical Device Industry
Medrio • April 18, 2019
An interview conducted by Medrio in which I discuss critical historical context behind the new MDR regulation, what you need to know about its implications for the clinical research industry, and other big topics.
Work with me
Verna@MantyMed.com
(650) 269-6847
Santa Cruz, CA