Medical Device Regulatory Services
Meet complex international market regulatory requirements facing medical device manufacturers
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Medical Device Manufacturers
With a deep understanding of worldwide regulations and requirements, DEKRA is a preferred partner of the healthcare and medical industries. We provide a range of certification, audit, and testing solutions focused on ensuring compliance with global standards, facilitating global market access, and increasing profitability. Our solutions are tailored to meet the specialized demands of manufacturers of medical devices and component parts.
Whether it is assessing conformity with CE-marking requirements or auditing to ISO standards, we tailor each solution to meet your needs.
Our solutions:
- Ensure compliance
- Enable global market access
- Build trust in your products
- Improve processes
- Protect people and property
Our Solutions
Our experts leverage proven strategies and proprietary tools to create customized solutions that meet your goals. From idea to implementation, DEKRA will guide you through each step as we assess your needs, develop an action plan, and implement your solution.
ISO 13485 Certification
Demonstrate continuous improvement and high-quality standards with quality management certification
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International Type Approval
Optimize time to market by integrating approval of new technologies across multiple countries and regulatory requirements
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ISO 27001 Information Security Management System Certification
Demonstrate IT security, data protection, and reliability of IT processes with ISO 27001 Certification
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ISO Management Systems Auditor Training
Public and private auditor training available virtually or in-person lead by experienced instructors
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Combustible Dust Testing
Prevent combustible dust explosions by identifying hazardous materials and assessing associated risks
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DEKRA Also Offers:
As the partner for safety at home, at work, and on the road, DEKRA has grown to become one of the largest safety organizations in the world. Today the company employs more than 45,000 specialists worldwide focused on increasing safety in all areas of life, including process safety consulting, industrial inspection, and product testing and certification. DEKRA operates in over 60 countries delivering a safer world through consulting, inspections, testing, certification, auditing, and training.
DEKRA is a trusted partner for medical device testing and accreditation, offering turnkey product certification services in nearly 200 countries and territories. With a worldwide presence and in-country partners, DEKRA provides the local certification and approval marks that you need to export your products to new markets around the world. Additionally, DEKRA is a notified body for certification of medical products in the European union and CE-marking of PPE.
Key Account Manager
fred.brown@dekra.com
