The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of scopes. Single-Use endoscopes offer a pivotal solution by eliminating the risk of patient-to-patient contamination. However, manufacturers face key safety considerations in bringing these products to market for medical use. This webinar will discuss laboratory testing and terminal sterilization considerations and steps to help ensure compliance with regulatory requirements within the US and EU (European Union). Key topics will include:
- Product and Packaging design
- Material compatibility with sterilization modalities
- Microbiological testing and process validation considerations to ensure a desired sterility assurance level is met
- Regulatory Compliance including compliance with ISO 13485 and adherence to the requirements of US and EU regulatory agencies
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.