In the modern medical device market, quality, safety, and compliance are of paramount importance. Regulatory requirements for medical devices have been continually tightening across the globe, leading to an increasing number of challenges faced by the industry. To ensure the safety and reliability of products, many companies are taking action by applying ISO 13485 standards to establish robust quality management systems. ISO 13485:2016 is a quality management standard designed for the medical device industry. It provides manufacturers and service providers with a framework to follow uniform standards for design, development, production, and related services to ensure that medical devices meet their intended purposes. In this rigorous environment, risk management is a critical component of ISO 13485 certification, ensuring products comply with evolving global regulatory requirements. To complement ISO 13485, ISO 14971 is designed for risk management, assisting manufacturers in ensuring proper risk control.

Anselm understands these challenges and requirements. Based on the Oracle Agile PLM, we offer an outstanding solution for implementing ISO 13485 management standards in product design, development, and quality work. This empowers your company to achieve ISO 13485 compliance, ensuring that product design and quality work align with the standards and enabling the management of intelligent assets throughout the product lifecycle. This collaborative management platform not only enhances product quality but also meets customer audit requirements and reduces development and compliance costs.

Let’s share a case study: Client B decided to use Oracle Agile PLM as ISO 13485 management software. They were dealing with data scattered across different systems, which led to ineffective implementation of CAPA or FMEA quality management processes during product design and development. However, through Agile PLM, they successfully established systematic management processes in compliance with industry standards, ensuring data was in the right place, and establishing a traceable quality management process, enabling them to better meet ISO 13485 requirements.

Agile PLM provides many powerful features to help your company effectively address ISO 13485 requirements:

Compliance with Electronic Record Standards: With the Agile PLM platform, you can establish an electronic record management information platform that complies with CRF-21 part 11, ensuring that your information is accurate and real-time.

IDMP Specification Document Management:
Construct document management operations in compliance with IDMP specifications, enhancing the efficiency of product (document) submissions, ensuring your company complies with various regulatory requirements.

Traceable Quality Management Processes:
With Agile PLM, you can establish traceable quality management processes, ensuring that products meet market regulatory requirements while reducing product development and compliance costs.

Anselm’s collaboration with Agile PLM will bring your company more efficient product management and quality control, helping you comply with ISO 13485 requirements to meet global medical device industry standards. Through our solution, your company will be able to operate more efficiently, gain a competitive edge, and achieve greater success in the market.

Contact us now and let Anselm Agile PLM help your company reach excellence and create more business opportunities!