Driving Innovation in Medical Device Development
Quality Systems Management
We have extensive experience in conducting Gap analysis, Failure Investigations, QMS Training, and Internal Audits. We help companies prepare for ISO or FDA audits, establish complaint reporting systems, develop CAPA procedures and tracking processes, complete management reviews, and maintain supplier quality agreements.
Product Development Support
We support companies with technical design reviews, requirements generation, sterilization specification and validation, and product verification and validation testing. We are committed to excellent Risk Management filing, including FMEAs, hazard analysis and risk-benefit analysis. We provide guidance in product development through product material selection, tolerance stack-ups, and design controls/requirements management and content generation. Additionally, we provide expertise in product packaging design (including full scope packaging/shipping validation), labeling specification and development, and preparation and management of clinical trial processes.
We support companies during their 510k submissions, including determining product class and predicate device, recall guidance and mitigation, biocompatibility assessments and schedules, preparation of CE marks and technical files, and guidance through regulatory body audits and remediation.
We provide excellent project management through every step of the process: from defining the project scope, establishing timelines, and qualifying and evaluating candidates for internal roles, to organizing project budget, assessing vendors, and facilitating contract negotiation.
We provide essential expertise in the manufacturing process, through process validation (including sample size justification and statistical analysis), full validation protocols and reports, fixture and tooling design, and clean room validation support.
We help companies bring their products to market by generating technical information for marketing and sales, such as Instructions For Use (IFU) and other technical labeling and packaging products.
Christie Johnson, Founder and Principal Consultant
Christie Johnson is a Mechanical Engineering graduate from Purdue University. Christie has worked for both large and small medical device companies, and has excelled in many facets of the life science industry including Engineering Design, Manufacturing, Quality Assurance, and Regulatory Affairs. She resides in Carmel, IN with her husband and two beautiful daughters. When she’s not working, she loves to be in the woods hiking or riding bikes, or volunteering with an animal rescue.
Expert Engineering, Quality Driven
Ready to see what Kasota can do for you? Contact us today for a free assessment and quote.
Kasota Engineering Inc. is a consulting firm specializing in the Life Science industry. We pride ourselves on guiding companies through challenges, and are passionate about driving innovation in Life Science.
Contact us today with any inquiries. We would be happy to learn about your project and give you an assessment.