ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is a Regulatory Standard with a focus on Safety and Efficacy.

Benefits of being an ISO 13485 certified company
If you manufacture or market a Class II or higher-risk classification device and sell it outside the United States, you probably need to be ISO 13485 certified. Certification can also expand your market access and improve your company’s profitability. Here are some of the long-term benefits of ISO 13485:

• It is the de facto standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
• ISO 13485 certification requires commitment and effort to attain, so it gives you additional credibility with potential customers.
• A refined QMS system will increase efficiency, enhance product quality, and improve customer service within your company.

Some of the key aspects of ISO 13485 include:

• Alignment of global regulatory requirements
• Inclusion of risk management and risk-based decision making throughout the quality management system
• Additional requirements and clarity with regard to validation, verification, and design activities
• Strengthening of supplier control processes
• Increased focus regarding feedback mechanisms
• More explicit requirements for software validation for different applications
• Alignment of global regulatory requirements
• Validation using pre-clinical and clinical evaluations
• Validation of packaging and distribution requirements
• A feedback section, including a new complaint-handling section and other guidance for customer communications
• Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

QSG will help you implement ISO 13485 or upgrade from ISO 9001

We understand the unique needs and manufacturing scenarios of the industry. With local offices around the world, our team of experienced QA consultants has helped hundreds of medical device and IVD manufacturers achieve ISO 13485 certification. Here’s how QSG can help you:

• We will fully customize your ISO 13485 quality system to meet your specific needs and make sure you are ready for a certification audit.
• Our ISO 13485 consulting teams will work closely with you to implement your QMS on time and on budget.
• We can recommend qualified third-party testing and certification firms that specialize in your device category.
• QSG will perform on-site ISO 13485 training for your key employees as part of the implementation project.

We guarantee you will pass your first ISO 13485 certification audit if you follow our plan.

The following ISO 13485 workshops are now available onsite or virtually:

ISO 13485:2016 Requirements Workshop
ISO 13485:2016 Internal Auditing
ISO 13485:2016 Lead Auditor, Exemplar Global Certified
ISO 14971:2019 Risk Management Requirements Workshop
Design Control Concepts and Implementation
FDA Regulatory Approval
GMP Compliance, Regulatory Affairs & Validation
Implementing the EU’s New Medical Device Regulation (MDR 2017/745)
Process and Software Validation
Process Validation: Principles and Protocols
Process Validation for the Medical Device and Pharmaceutical Industries
Software Development for Medical Device Manufacturers

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