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Participate in the TMDA MedTech Supplier Summit!!
Oct 21, 2-4pm – TMDA MedTech Supplier Summit: Market Place Solutions from Bench to Bedside
We are inviting suppliers/vendors providing products/services across the entire medical device life cycle to participate in our complimentary summit. All suppliers/vendors may give 2-5 minute pitch to all attendees. TMDA industry participants and attendees are typically start-ups and small to medium size medical device manufacturers.
Suppliers/Vendors may include, but are not limited to: device designers, validation testing labs, human factors testing, prototypers, contract manufacturers, regulatory consultants, quality consultants, etc.


Qualio – The #1 Cloud-based QMS for Life Sciences 

Qualio’s quality management platform is ready-to-use and cloud-based. Ranked as the “easiest to use” and “fastest implementation” Qualio unites your teams, processes, and data all in one place so you can not only get to market quickly and scale successfully but be 100% audit-ready. Qualio is built to make FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485 & 14971 audit-readiness easy for your team. Customers love our simple and secure document management, training, quality events, design control, risk management, and audit-ready reporting that are actually “fun to use”. No joke… our customers actually call it fun! 😉
Learn more and request a demo at

From Lab to Launch Podcast

We feature innovators and entrepreneurs on the front lines of life sciences each week on our podcast From Lab to Launch. We’d love to hear your story and represent Texas! Learn more and apply here.

Upcoming Events & News

Live Webinar: Passing an Audit: Pro Tips from a QA Expert Panel. Register for this live webinar on Tuesday, June 15, 2021 at 1pm CDT to hear leading Quality experts at Qualio, MWA Consulting, and Cirris, discuss the best ways to approach and pass an audit. 

News: Qualio raises $50M to expand accessibility of our cloud-based eQMS at global scale and fuel significant investment in product and engineering team growth. Ready more on our press page.

Would you like to be considered for our spotlight company? Fill out this application.

BioAustinCTX Highlights

Austin Technology Council is bringing back in person events! Don’t miss your chance to actually meet and greet people without a computer screen. Spaces are limited so register today!


June 1
9am – 4:30pm

NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials

The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
June 2
All Day

 eClinical & Clinical Data Management Innovation Conference

This virtual event has been exclusively designed for the cutting-edge data & analytics leader, focused on aligning data strategy with digital transformation, leveraging data analytics to increase business value and use data to promote growth.
June 8
9am CDT
60 minutes

Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing

This webinar will showcase a comprehensive approach to understand potential risks to lyophilized drug product quality based on chemical and physical performance testing. The discussion will cover key considerations in the study design for manufacturability and packaging leveraging this analytical approach.
June 8 – 9
All Day

NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials

The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
June 9
9am CDT
60 minutes

Developing Effective Clinical Supply Chain Strategies Utilizing Forecasting Technology

Building an effective clinical supply chain that factors in the increasing challenge of getting the necessary drug to the patient in a timely manner has never been so important. Discover how Almac partners with pharmaceutical and biotech sponsors to build optimized and efficient supply chains in their upcoming webinar
June 15
1pm CDT
60 minutes

Passing an Audit: Pro Tips from a QA Expert Panel

For quality teams in life science organizations, implementing the best ways to prepare for and pass internal and external audits can be challenging. Getting everything prepared for an audit is a necessary, yet daunting task. While there is no one way to approach an audit, our experts will help answer common questions about audits to help you feel more confident.
June 16
1pm EST
60 minutes

Microfluidic bubble sensors, Non-invasive liquid level sensors, and Autoclavable force sensors.

New and innovative approaches to drug discovery tools, in-home dialysis care, diagnostic lab automation, and haptic feedback surgical tools have generated significant demand for equally innovative sensors to provide control data for the safe and accurate performance of these medical devices.
June 16
8pm CT
60 minutes

The Critical Role of Biostatistics in Streamlining the Preclinical to Clinical Pathway

Obtaining market approval for a new product can create several clinical challenges for medical device Sponsors. One way in which to tackle these challenges head-on is to develop effective biostatistics processes and plans early in the development process to navigate these complexities.
June 18
10am MDT
60 minutes

Internal Audits: Outsource or Inhouse?

In this webinar, we will discuss why you have to perform QMS Internal Audits, what the requirements are and top mistakes made by internal auditors. We will also look at the advantages of insourcing and outsourcing the audit.
June 22 – 23
All Day

Biological Safety Training – June Course B

This two-day training course is designed for those who have received certification in the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification Course. Objectives of this course include practice beyond the basics of Table A.1 in ISO 10993, with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials
June 22 – 24
All Day

FDA Medical Device Regulations

Join Texas Medical Device Alliance (TMDA) for their free webinar for a panel discussion on the quick pace changes seen in light of Emergency Use Authorization.
July 15
2-4pm CDT

Risk Management True Quality Summit Series

Medical device risk management is not optional – it is a regulatory requirement worldwide. But with today’s medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy. The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.
Sept 22 – 23
All Day

BioNTX iC3 Summit 2021 – Reignite!

Launched in 2014, the iC3 Life Science Summit serves as a forum for leaders to discuss strategic issues, exhibit the broad spectrum of North Texas life science products and services, and to network with each other to grow business through collaborative efforts. Register now for this in person event.
Oct 21
2 – 4pm CDT

TMDA Supplier Summit

This summit is tentatively set to meet in person. Discuss medical device marketing with an audience Q&A session. Register today to reserve your spot.

Austin Technology Council Calendar of Events

Texas States Small Business Development Center Network Calendar of Events

Women in Business Virtual Calendar of Events

View the full list of virtual events.

Temple Health & BioScience District’s (THBD’s) E-Learning Series Webinars Library

NAMSA’s Podcasts Calendar of Events


The Ultimate Guide to Design Controls for Medical Device Companies

This comprehensive guide walks you through every step of the process and gives specific recommendations on what you can start doing today to ensure compliance while getting your device to market faster. 

State of Medical Device Report 2020

Medical device companies, more specifically product development and quality teams, are expected to deliver innovative, life-changing medical device(s) at a rapid pace, all while maintaining compliance and achieving true quality – no pressure. This report shares the results of hundreds of survey responses from medical device professionals across the globe. They shared helpful insights and critical information about how their companies are currently managing both their product development and quality activities.

Accelerate Critical Scientific Discovery

See the winners of the recent ATCC Innovation Challenge! Through this challenge, we called upon innovators throughout the scientific community to submit a proposal of how they are using ATCC products in a novel way in infectious respiratory disease research or COVID-19 research. After receiving numerous submissions, we are pleased to announce the four winners of the challenge below. We’re proud to be a part of the scientific community that is working toward solving the COVID-19 crisis and we look forward to these innovative ideas coming to fruition.

Software as a Medical Device

Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis of clinical conditions and diseases. Even when software has been included as part of medical devices, in recent years it has been an increased use of software as a medical device by its own. This situation has promoted the regulation of Software as a Medical Device (SaMD) by some regulatory agencies

Changing the Face of Patient Recruitment

As the pandemic forced some clinical trial sites to shut down and numerous ongoing studies to pause, patient recruitment also slowed to a crawl, piling one more challenge onto an area that traditionally is fraught with difficulty. Despite these challenges, the pandemic has
also had a positive effect on the patient recruitment process. Learn more in a study released by PharmaVOICE.

How To Eliminate The Gate In Medtech Product Development’s Phase-Gate Approach

Check it out to learn more about how Boulder iQ’s “Think Smart” approach to product development can save time – and money – in getting life sciences products to market. This process reorders the steps in product development to help speed up the processes that typically get bogged down in the traditional phase-gate approach to medical device development.

World Pharmaceutical Frontiers

Get the latest digital edition by WorldPharma. The publication provides the latest industry thinking in all areas of pharmaceuticals and is essential reading for those who want to thrive while navigating the impact of Covid-19.

Local Industry News

Bridging the Health Innovation-Impact Gap: How Dell Medical School Created A High-Value Accelerator

UT Austin’s Dell Medical School has created a brand-new type of accelerator, Texas Health Catalyst (THC), to advance the progress of impactful ideas from bench to bedside and tackle some of today’s biggest challenges. 

Across the Pond

Outsourcing in Clinical Trials in Eastern Europe 2021

Arena International are pleased to announce our first ever Outsourcing Clinical Trials event to focus on the challenges specific to running trials in Eastern Europe. Taking place on our innovative virtual platform, this event brings together senior leaders from across the industry to discuss everything you need to know when running clinical trials in Eastern Europe. 


Texas Health Catalyst Application

Do you have a discovery or idea for a product to improve health?

Make your project more attractive to potential funders and partners: Apply to Texas Health Catalyst for an opportunity to receive commercialization support and to work with mentors with experience taking health care products to market.



Sept 20 – 21
All Day

2021 International Life Science Women’s Conference

The Life Science Women’s Conference (LSWC) creates an environment where women working or desiring to work in all areas of life science companies and academia can gather to network and collaborate with other women with regard to entrepreneurship, professional development, inspiration, funding, career enhancement, scientific and technical updates.

Is ‘Strategic Discrimination’ Happening in Medtech?

Gender economics experts weigh in on an interesting finding from this year’s Medtech Salary Survey. In comparing the 2021 findings to past reports, Pedersen noticed that the gender ratio in the medtech industry has improved dramatically over the past five years.

We Need More Women Founders, Now, More Than Ever

Women-led startups employ more women, and when considered as a group, are more likely to succeed. That’s why the NYU School of Business’s Endless Frontier Labs launched an initiative to fund women-founded startups: to help us reclaim our place as foundational contributors to global prosperity.

Celebrating Pioneering Women in Science

AWIS is highlighting contributions of Asian American and Pacific Islander women in STEM on their historical figures page. Learn more about these amazing women and share their accomplishments in the field.

Using nanobodies to block a tick-borne bacterial infection

Researchers led by veterinary biosciences professor Yasuko Rikihisa have developed llama-derived nanobodies derived that block Ehrlichia chaffeensis. The tick-borne bacterium is difficult to kill with standard antibiotics because it replicates inside immune cells, and Rikihisa’s engineered nanobody blocked three functions of a protein the bacterium uses to take over immune cells.

Plant-derived COVID-19 vaccine candidate starts rolling review with Health Canada

Health Canada has begun a rolling review of data on Medicago’s COVID-19 vaccine based on coronavirus-like protein particles grown in live Nicotiana benthamiana plants, which is easier to scale up and produces vaccine substance faster than egg-based production, and both vaccines and antibodies can be produced using the same platform, said Nathalie Landry, the company’s executive vice president of scientific and medical affairs.

Hockfield joins Repertoire BOD

Massachusetts Institute of Technology President Emerita Susan Hockfield has joined the board of directors at Repertoire Immune Medicines, which was formed in 2019 with the merger of Torque Therapeutics and Flagship Pioneering. Repertoire is developing immunotherapies for metastatic solid tumors and type 1 diabetes.

Career Connections

We equip underserved jobseekers with 21st-century skills and connect them to Digital Marketing careers across the US. With a focus on underserved communities, we amplify the online presence of small businesses, while launching the careers of jobseekers.

Karoleen Joseph, Seeking Opportunity

I finished my degree in Chemical Engineering along with a Business minor from Texas A&M in 2016. Since I have been working for a large organization as a Project Engineer III / Advanced Field Service Engineer I’ve gained experience in manufacturing and custom automation, and in the process of completing my PMP Certification. While I have grown and excelled at this company, I always knew that my passion was to work for an organization that contributes towards a better cause. I would be thrilled to work and grow with a company that contributes to the medical field in some way or form in the Austin or Round Rock area. I do understand I am making a field change (in a way) and some companies look for people that have prior experience in the field they are hiring for. However, I am extremely passionate about this change and I know I would be able to excel in it in a short period of time given the opportunity. Please contact me via email or LinkedIn


Multiple Positions
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Aeglea Biotherapeutics

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AMDM IVD Job Board


Multiple Positions
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Austin Technology Council (ATC) Jobs

Babylon Health

Multiple Positions
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Black Diamond Networks

Multiple Positions

Commissioning Agents (CAI)

Multiple Positions

FDA Quality and Regulatory Consultants (FDAQRC)



Multiple Positions
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Molecular Templates

Multiple positions
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Multiple Positions

Skills Alliance

Multiple positions
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Syneos Health

Multiple positions
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Austin Chamber Talent Ambassador program 

We partner with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connect them to local schools, post-secondary institutions, and those facing barriers to employment.


We are seeking volunteers to help collect and compile data to map the healthcare landscape in Austin. If interested, please reach out to Scott Collins 


ATX Women in MedTech

Austin Technology Council

Austin Health Tech Meetup

Austin Technology Incubator (ATI)

Beam Founders

BioAustin LinkedIn Group

BioMed San Antonio


Capital City Innovation (CCI)

Central Texas Angel Network

Health Technology Forum Meetup m-Austin/

Bio El Paso-Juarez

Health Wildcatters, Dallas

Austin Chamber of Commerce


Temple Health & Bioscience District (THBD)

Texas Healthcare and Bioscience Institute (THBI)

Texas Biomedical Research Institute, San Antonio

Texas Health Catalyst

Texas Medical Device Alliance (TMDA)

Texas Medical Device Alliance (TMDA) LinkedIn Group

The Health Cell, San Antonio

TMCX/TMCX+, Houston programs/tmcx-plus/

Top Austin-Area Medical Device Companies

Velocity Texas, San Antonio

Women in Bio-Texas (WIB-TX, Austin & Houston)


With warm regards,

Amy Shepherd, Christine Scheve, Dana Abramovitz, Elisa Maldonado-Holmertz, Gretchen Upton, Joe Skraba, Lance Anderson, Ryan Baird, Sandie Roth, Scott Collins, and Tim Sullivan, on behalf of BioAustin, Texas Medical Device Alliance (TMDA), and Austin Health Technology (AHT)