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For over 25 years, CAI has been passionate about helping development-stage companies get their product to market faster. Any misstep on the path to commercialization drains capital, impacts valuation, and delays time to revenue. Most importantly, delays can impact patient access to novel, life-saving therapies. Our industry experts work with you to characterize your product and process, and to apply the principles of quality by design, quality risk management and industry best practices to help you reach each milestone on the path to commercialization in the most efficient manner. Our integrated project delivery model enables you to accelerate process validation, tech transfer, manufacturing scale-up, vendor selection, quality system implementation and regulatory affairs from early clinical trials through scale-up to commercial manufacturing.
CAI serves clients in the following business areas:
- Commissioning & Qualification
- Building Commissioning
- Asset Management & Reliability
- Quality, Regulatory, & Compliance
- Human Performance
- Process & Manufacturing Technology
- Owner’s Project Management
- Automation & Information Technology
Join AHC and TEXGHS to discuss how home-based health care (remote patient monitoring) increases pandemic resiliency in communities. This June, we are focused on remote patient monitoring. We’re bringing together Austin’s health leadership and regional entrepreneurs in health innovation for an enlightening talk and panel conversation about a health security topic of interest followed by lightning pitches from three promising later stage startups.
Karl Handelsman is the Founder and General Partner of Codon Capital, established in 2013 to invest in early-stage biotech teams uniquely qualified to build breakthrough technical solutions in therapeutics and synthetic biology. Karl has been working with extraordinary teams that have a track record of success for over 20 years. Codon supports teams in advance of the Series A to discover the highest value product for their technology. Codon also helps teams establish a capital efficient development plan with the goal of demonstrating value within 18 months of the Series A financing. During this seminar, Karl will walk you through the journey of becoming a founder and entrepreneur.
It is important to understand the role that regulatory affairs plays and how it could can help your business / start-up flourish and avoid unnecessary obstacles. At this event, Bobbi Drais from Drais Regulatory Consulting, LLC will introduce you to the regulatory function and provide a history of the FDA and its oversight of the biotech and life sciences industry.
The IBE is a non-profit celebrating 5 years of helping entrepreneurs accelerate the flow of ideas to the marketplace. The IBE program is a 5 day experiential program that includes a mix of classroom work and hands on project work. Advisors work with participants over the 5 day program to develop and refine their pitch and present to an investor panel on the final day. Since its inception, the IBE has helped over 40 companies launch and over 50 corporate projects see success in the marketplace.
The BioNTX iC³ Life Science Summit serves as the forum where leaders come together to discuss strategy, exhibit the broad spectrum of North Texas bioscience research, and where the latest innovation, products and services can be seen. Attendees range from the startup community through large multinationals representing industry sectors such as biotech, pharmaceuticals, healthcare companies, academic research institutions, innovators, and leaders. Also attending will be business development executives, vendor partners, investors, and talent seeking new opportunities.
Webinars & Virtual Events
A big challenge with all medical device manufacturers is to be compliant with any regulations applicable with their product. In the case of the United States it will include 21 CFR Part 820 which is a set of regulations from the FDA that outlines the current good manufacturing practice (CGMP) requirements that manufacturers must follow with regards to their quality system. Register for this free webinar where Anne Holland, CEO of QA Consulting with 20+ years experience advising medical device companies on regulatory and quality needs, will share some preventative actions that your medical device company can take to minimize the possibility of receiving a 483 which in some cases could result in a product seizure.
NAMSA’s Biological Safety Training Series is geared toward medical device professionals who require a working knowledge of biological safety and biocompatibility.
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 A).
Level up your medical device skills and grow your career! From quick, practical lessons to comprehensive certifications, you’ll learn everything you need to know about keeping up with the medical device industry.
Apply to Texas Health Catalyst @Dell Medical School for commercialization support for your product idea/invention:
Apply to Texas Health Catalyst for an opportunity to receive consulting and commercialization support for your health product idea or discovery. Eligibility: Austin entrepreneurs, startups & UT faculty/researchers/students. Areas of interest: Therapeutics, Devices, Diagnostics/Research Tools, Digital Health/Software. Deadline: June 15th 2022.
More information and application link > https://dellmed.utexas.edu/applythc.
Austin Community College
Austin Community College biotechnology or computer science interns are available Email Kathryn Naughton for more information
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.
What if, there was a one-stop shop for candidates and companies looking for top medical device opportunities and talent, worldwide Increase your network with more than 150,000 medical device industry professionals to access exclusive top talent and list incredible jobs in the medical device industry. The job board will always be free to job seekers, and hiring companies will receive their first 90 days of unlimited job postings free.
Austin Technology Council (ATC) Jobs
Black Diamond Networks
Commissioning Agents (CAI)
FDA Quality and Regulatory Consultants (FDAQRC)
Life Science Conferences, LLC
• Determines grant proposal concept by identifying and clarifying opportunities and needs, studying requests for grant proposals (RFPs), and attending strategy meetings.
• Prepares grant proposals by determining concept, gathering and formatting information, writing drafts, and finalizing.
• Supported by the BioAustinCTX Board
UT needs your help
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 fill our volunteer form.