PROFAL INDUSTRIE, has successfully completed the Surveillance 01 audit for IOAS accredited ISO 13485:2016 and ISO 14971:2019 certifications, reinforcing its commitment to quality and risk management in medical devices.
PROFAL INDUSTRIE specializes in the design, manufacture, importation, and distribution of sterile and non-sterile consumables of medical devices and sterile and non-sterile in vitro diagnostic medical devices for clinical use. The company also engages in the importation and distribution of active and non-active medical devices and in vitro diagnostic medical devices. By achieving these prestigious certifications, PROFAL INDUSTRIE ensures compliance with international medical device regulations and customer satisfaction.
The scope of the certification includes Design, manufacture, importation and distribution of sterile and non-sterile consumables of medical devices and sterile and non-sterile in vitro diagnostic medical devices for clinical use. Importation and distribution of active and non-active medical devices and in vitro diagnostic medical devices.
What is ISO 13485:2016?
ISO 13485:2016 is a globally recognized standard that specifies the requirements for a Quality Management System (QMS) in the medical device industry. It ensures that organizations comply with stringent regulatory requirements and maintain consistency in product quality, safety, and performance.
What is ISO 14971:2019?
ISO 14971:2019 focuses on the application of risk management to medical devices. It provides a structured approach to identifying, evaluating, and controlling risks associated with medical devices, ensuring the highest standards of patient safety and regulatory compliance.
Benefits of ISO 13485:2016 and ISO 14971:2019 for PROFAL INDUSTRIE :
Enhanced Product Quality: ISO 13485:2016 ensures that all medical devices meet high-quality standards, ensuring reliability and compliance.
Risk Management Excellence: ISO 14971:2019 helps mitigate potential risks, ensuring the safety and effectiveness of medical devices.
Regulatory Compliance: The certifications demonstrate adherence to global medical device regulations, fostering trust among customers and stakeholders.
Operational Efficiency: Implementing these standards streamlines production processes, reduces waste, and enhances overall efficiency.
Market Competitiveness: Achieving these internationally recognized certifications strengthens PROFAL INDUSTRIE’S market position and facilitates access to global markets.
Customer Confidence: By adhering to the highest industry standards, the company reinforces its commitment to delivering safe and high-quality medical devices to its clients.
With these certifications, PROFAL INDUSTRIE continues its dedication to quality, risk management, and regulatory compliance in the medical device sector. The implementation of ISO 13485:2016 and ISO 14971:2019 will further enhance its processes and contribute to the delivery of superior medical products to its valued customers.
