ISO 13485:2016 (MDMS)
ISO 13485:2016 - Medical Devices
TUV SAG provides professional certification and evaluation services for ISO 13485:2016, the internationally accepted standard for Quality Management Systems in the medical device sector. Organizations engaged in the design, development, manufacturing, installation, and maintenance of medical devices must adhere to this standard.
According to the Saudi Food and Drug Authority (SFDA), the U.S. FDA, and the European Union’s Medical Device Regulation (MDR), ISO 13485:2016 certification from TUV SAG shows that you are dedicated to safety, compliance, and reliable product quality.
Benefits
Medical Devices
A structured framework for creating and sustaining a Medical Devices (MDMS)that is adapted to the particular safety, performance, and regulatory requirements of the medical device industry is offered by ISO 13485:2016.
Regulatory Compliance
FDA Quality System Regulation (QSR) compliance, CE Marking, and SFDA licensing are just a few of the important regulatory requirements that can be met with TUV SAG certification. It is a fundamental prerequisite for businesses looking to get permission to join and function in international healthcare markets.
Product Safety and Risk Management
The standard promotes active risk management and the decrease of adverse events while enforcing strong design, production, and post-market control procedures that put patient safety first.
Consistency and Quality
In order to create medical devices that are safer, more dependable, and compliant, ISO 13485:2016 encourages the adoption of standardized procedures, documentation, and quality controls.
Customer Satisfaction
Businesses that have earned TUV SAG’s ISO 13485 certification demonstrate their commitment to quality control and product integrity, which boosts consumer confidence and fosters trust with regulators, distributors, and healthcare providers.
Improved Efficiency
By putting the standard into practice, inefficiencies can be found, waste can be cut, and overall productivity can be raised, which improves resource use and lowers operating expenses.
Competitive Advantage
ISO 13485:2016 certification is a crucial differentiator in the expanding and cutthroat healthcare industry, boosting credibility and facilitating partnerships, procurement, and tender success.
Global Market Access
International acceptance of ISO 13485 and alignment of your company with international quality and safety standards through TUV SAG certification open doors to important international markets.
Continuous Improvement
In order to foster a culture of continuous innovation and improvement within your company, the standard calls for frequent internal audits, management reviews, remedial actions, and monitoring activities.
How to complete the ISO Certifications:
1. Choose the Relevant ISO Standard: Select the ISO standard that fits your business needs .
2. Conduct Gap Analysis & Plan: Identify gaps in current processes and prepare an implementation plan with roles and timelines.
3. Develop & Implement Documentation: Create required policies, procedures, and records; train employees and apply the system.
4. Perform Internal Audit & Management Review: Audit your processes internally and review performance at the management level.
5. Take Corrective Actions: Fix any issues or non-conformities found during the internal audit to ensure full compliance.
6. Undergo Certification Audit: A certified external body conducts an audit; if successful, you receive the ISO certificate .
Our Services
TUV SAG
Your Trusted Brand in Industrial Excellence
We deliver end-to-end services that support quality, safety, and compliance across diverse sectors.
Our Office Address
Office #1 3rd Floor Jubail 31951 Kingdom of Saudi Arabia P.O. BOX #1357
