At Sterwell, we specialize in providing expert consulting services to the medical device industry, focusing on critical areas such as sterilization, biological evaluation, microbiology, and risk assessment. We work closely with our clients to ensure their products meet the highest safety and regulatory standards throughout the entire development and manufacturing process. With over 40 years of experience, we possess a comprehensive understan... Read more
Our services stand out in the medical device consulting industry due to its unparalleled expertise and decades of experience. With over 40 years dedicated to sterilization, biological evaluation, microbiology, and risk assessment, our deep knowledge and commitment to excellence make us a trusted partner for medical device professionals. We understand the intricacies of regulatory requirements and the critical importance of product safety, wh... Read more
Sterwell was founded in 2020 by David Parente, a seasoned expert with over 40 years of experience in the medical device industry. After a distinguished career, our founder transitioned into consulting to continue serving the industry from a new vantage point. The decision to start Sterwell was driven by a deep passion for helping others and a commitment to leveraging decades of knowledge to assist medical device professionals in navigating t... Read more
- Association for the Advancement of Medical Instrumentation
- AAMI Sterilization Standards Committee Working Groups
- Industrial Ethylene Oxide Sterilization
- Radiation Sterilization
- Microbiological Methods
- General Criteria for Sterilization Processes
- Sterilization Residuals
- Sterility Assurance Level (SAL)