NanoSono nanomaterials technology transforms almost any medical device, fabric, filters, or any type of surfaces into an antibacterial surface and can prevent biofilm. Such capability makes them safe, effective, and long-term antimicrobial protection within the healthcare industry, making it more relevant and critical during these challenging times with the COVID-19 epidemic.
Challenge
NanoSono was established in 2013, and during this period spent years of research and development for an effective solution to the growing problem of contaminations and infections. The company developed an arsenal of antibacterial technologies that can be easily coated on many medical devices, fabrics, filters as well as a myriad of consumer products using a simple process that can virtually eradicate the most common types of bacteria endangering people.
In order to grow and penetrate international markets, the company had to face various regulatory challenges. At this point, NanoSono decided to use the services of RS NESS – a company that provides a comprehensive solution for the Life-Science industry.
From the Development stage, RS NESS had the extremely challenging mission in transferring NanoSono to a commercial production plant to the stage of successfully passing a Medical Device ISO13485 audit, all this within four months.
ISO 13485 is the international standard for the certification of a Quality Management System for the medical device industry and it is considered the “passport” for many international markets
Solution
In preparation for the ISO13485 audit, NanoSono approached RS Ness for support and management in Validation, Maintenance, Calibration as well as Quality Assurance activities.
The scope of the project includes:
- Gap Assessment and Validation Master Plan (VMP)
- Risk Management
- Computerized System Validation (CSV)
- Cleaning Validation
- Equipment Qualification
- Production process validation
- Analytical Lab, Micro Lab Validation
- R&D Verification
- Maintenance, Safety, Calibration, Cleaning procedures and implementation
- Quality Management System (QMS) establishment & implementation
Design Control Assurance
To meet the goals, two teams were assigned to the project: a team responsible for establishing a quality system, and a team responsible for validating the facility, equipment, and processes. In addition, a detailed Gantt chart was prepared, to meet the goal within the scheduled time frame which was presented to NanoSono management in a weekly status meeting.
Result
- During four months, the expertise, engagement, and dedication of the team members made it possible to achieve the goal.
NanoSono passed the audit successfully and received an ISO 13485:2016 Certificate in September 2020 for the Development and Production of its Products.
How can we help
RS NESS supports Life Science companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need when you need it.
We can assist you with a gap assessment to help you create an appropriate project plan, and support the transition throughout the Regulatory, Clinical, QA, Validation, and Engineering processes.
If you are planning to get ISO13485 certification, please contact us for support.
