What is ISO 13485 (Medical Devices – Quality Management System) Certification in USA?
ISO 13485:2016 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.
ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System in the medical device industry.
ISO 13485 certification 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
ISO 13485 certification in USA is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification in USA is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
Quality Catalyst is one of the best consulting firms that offer ISO 13485 Certification and Consulting in USA. As the leader in professional training, we draw on our years of worldwide experience to provide effective learning and development opportunities. We make a difference to individuals, teams and businesses, nurturing talent and enabling continuous organizational progression. So get started on your road to ISO 13485 Certification today.
What are the steps to achieve ISO 13485 Certification in USA?
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 regulatory requirements. Steps to achieve ISO 13485 certification in USA
- Planning the quality system – Writing a quality manual is insufficient, you need a documented quality plan for implementing changes to your quality management system.
- Conduct A Gap Analysis – One of the most important steps when implementing ISO 13485 is performing a gap analysis.
- Develop an implementation plan
- Provide training and carry out your plan
- Perform internal audits and reviews
- Complete the third party audit and Certification process
Benefits of ISO 13485 Certification in USA
An ISO 13485 Certification in USA can provide numerous benefits to medical device companies. Some of the benefits of ISO 13485 certification include:
- Legal Compliance: ISO 13485 certification requires compliance with all legal and regulatory requirements.
- Reduced Operating Costs: ISO 13485 helps you to continually improve your processes and make them more efficient over time, saving your organization money.
- Improved Customer Satisfaction: A medical device QMS helps you to provide more consistent quality in your products and services, making your products more reliable and better able to meet customers’ needs.
- International Expansion Opportunities: ISO 13485 is internationally recognized as a sign of product quality and is the first step to regulatory approval in many major markets. These qualities mean ISO 13485 certification can help you to expand your business into new markets.
How to avail ISO 13485 Consulting and Certification Services in USA?
ISO 13485 Certification and Compliance is a highly accepted and desirable requirement in USA because of the country’s popular economic, political and cultural reputation. Though the decision to avail our services is yours, here is how to get ISO 13485 Consulting and Certification in USA. Drop an enquiry to us and we will assign a dedicated expert who will provide a free consultation on the process and give a cost proposal suiting your exact requirement and budget. We provide ISO 13485 Certification and Consulting services in USA and in prominent regions like New York, Los Angeles, Chicago, Washington, Seattle, Boston, Chicago, Houston, San Francisco, Phoenix, Philadelphia, San Diego, Austin, Miami, Detroit, Dallas etc.