Katie Brinkman Joins Hohenstein Medical to Lead Biocompatibility Program
Katie Brinkman brings over 15 years of expertise in biological sciences to her new role at Hohenstein Medical. Renowned for her meticulous approach to biological risk evaluation, Brinkman's experience will significantly enhance the company's biocompatibility services in the medical device industry.
A Focus on Medical Device Biocompatibility
In her capacity as biocompatibility program manager, Brinkman will spearhead the development and strategic advancement of Hohenstein Medical's biocompatibility offerings. Her responsibilities will encompass essential areas such as chemical characterization, ISO 18562 gas pathway testing, and ethical non-animal assays. She will also be involved in consulting for biocompatibility assessments, creating biological evaluation plans and comprehensive reports.
Dr. Timo Hammer, CEO of Hohenstein Medical, expressed enthusiasm about Brinkman's appointment. "We are excited to welcome Katie to our team, aiming to provide our clients with unparalleled services rooted in high international standards for regulatory studies and laboratory competency," he remarked.
Brinkman's Impressive Background
Before her tenure at Hohenstein Medical, Brinkman honed her skills in biocompatibility roles at renowned organizations such as Cook Research Incorporated, NAMSA, Abbott, and Ethicon Endo-Surgery, Inc. During this time, she authored numerous critical biocompatibility and toxicological risk assessment reports, supporting various global regulatory submissions.
Her breadth of experience encompasses all phases of the medical device lifecycle, ranging from initial product development and design modifications to compliance with European Union Medical Device Regulation (EU MDR) and post-market evaluations.
Katie's Vision for Hohenstein Medical
Brinkman articulated her excitement about joining the Hohenstein Medical team, stating, "Biocompatibility is a nuanced field, and I am eager to combine my technical expertise with Hohenstein's commitment to personalized customer support. I aim to create a biocompatibility program that facilitates a seamless process for our clients."
To support her in this role, Brinkman carries six years of experience as a subject matter expert in biocompatibility. She is certified as a Biological Safety Specialist by NAMSA and possesses extensive knowledge in the ISO 10993 standards and related areas.
The Importance of Biocompatibility Testing
Hohenstein Medical stands out in the industry as it is one of the few medical device testing facilities accredited for chemical, physical, and biological safety testing. The company’s comprehensive approach ensures consistent evaluations, fully aligned with requirements set by the FDA, MDR, and ISO 10993 standards.
This includes critical evaluations such as ISO 10993-1, which focuses on risk management processes, along with ISO 10993-12 for sample preparations and ISO 10993-18 for materials characterization. By maintaining these rigorous standards, Hohenstein Medical guarantees their clients confidence in compliance with global regulatory mandates.
Overview of Hohenstein Medical Services
For insights into Hohenstein's medical device testing capabilities, the company delivers biocompatibility testing for various medical devices. These services include chemical screenings, biological in-vitro testing, and microbiological evaluations which encompass bioburden and barrier effectiveness checks.
This broad spectrum of testing options is meticulously tailored to meet the specific requirements of manufacturers, focusing on the intended use, contact classification, and the pathway of regulation.
Commitment to Quality and Customer Care
Hohenstein Medical emphasizes a collaborative approach with its clients, ensuring that study designs are customized when existing methods may not be adequate. This dedication to customer service is rooted in the company's vast experience and commitment to providing quality solutions.
As a division of Hohenstein Laboratories, the organization boasts over 75 years of scientific expertise and has played a vital role in developing international standards within the testing industry.
Media Contact
For inquiries regarding Hohenstein Medical and its services, please reach out to Casey Strauch, Marketing Director. She can be contacted at +1 612 239 8830 for all relevant information.
Frequently Asked Questions
What expertise does Katie Brinkman bring to Hohenstein Medical?
Katie Brinkman brings over 15 years of experience in biological sciences, focusing on biocompatibility and medical device testing.
What is Hohenstein Medical's focus?
Hohenstein Medical specializes in biocompatibility testing for medical devices, including chemical screenings and biological evaluations.
Why is biocompatibility important in medical devices?
Biocompatibility ensures that medical devices are safe and effective for their intended use in patient contact while complying with regulatory requirements.
What standards does Hohenstein Medical adhere to?
Hohenstein Medical adheres to several key standards, including FDA guidelines, European Medical Device Regulation (MDR), and ISO 10993.
How does Hohenstein Medical customize its testing services?
Hohenstein Medical collaborates closely with clients to tailor study designs based on specific needs when standard methods are insufficient.
