ISO 13485:2016 is the updated standard version designed to accommodate the most current quality management system practices, such as technological and regulatory expectations and guidelines. The new version places a stronger focus on risk management and risk-based decision-making, in addition to modifications relating to the increased regulatory requirements for supply chain organisations.
ISO 13485 was published to assist manufacturers of medical devices in developing a QMS that ensures the effectiveness of their processes. It guarantees the safe design, development, production, installation, delivery, and disposal of medical devices for their intended use. ISO 13485 is essential for medical device designers, manufacturers, and distributors. In addition, suppliers and service providers can increase a company’s marketability as many manufacturers require Certification to conduct business with a vendor.
Patient safety is highly dependent on the quality and consistency of medical products in medical device manufacturing. Ensuring the effectiveness, control, and maintenance of your QMS is crucial for customers, stakeholders, patients and users, and regulatory agencies.
ISO 13485’s value lies in its implementation and ability to facilitate a comprehensive audit of the system’s efficacy and certificate of enrolment.
It instils greater confidence in the manufacturer’s capacity to achieve and maintain regulatory compliance consistently. In addition, it can aid in minimising surprises and failures that could compromise patient safety and harm a manufacturer’s reputation.
Anitech’s QMS Consultants have experienced professionals with hands-on industry experience designing and implementing robust Quality Management Systems like ISO 13485.
Our team is dedicated to offering value to our customers and will create a strategic plan to help you enhance and maintain the quality of medical devices.
We also offer Compliance and will work as an extended team to aid your organisation.
- ISO 1485 design, implementation, and Compliance
- Documentation of procedures and Reports on findings
- Internal Audits
- Professional and Committed ISO Consultants
If you want our ISO 9001 Consultants to help you implement a robust Quality Management System for your Medical Devices, perform internal audits, and provide Compliance Support, feel free to reach out to us at 1300 802 163 or e-mail – email@example.com.