As a medical device manufacturer you should consistently deliver devices that are safe and effective. ISO 13485:2012 is the international standard recognized for medical device regulations around the world.The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

Implementation of a Quality Management System with several enhancements

Risk Management approach to product development and product realisation

Validation of processes

Compliance with statutory and regulatory requirements

Effective product traceability and recall systems

Advantages of ISO 13485

Customer satisfaction – through delivery of products that consistently meet customer requirements

Reduced operating costs – through continual improvement of processes and resulting operational efficiencies

Improved stakeholder relationships – including staff, customers and suppliers

Improved risk management – through greater consistency and traceability of products and use of risk management techniques

Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers

What we do

“KABB Certifications” is one of the leading quality assurance and management consulting firms based in Pitampura, Delhi, India, serving our clients globally. We provide highly distinguished ISO 13485:2012 certification services through our team of skilled management experts in the field of ISO 13485:2012 certification training, implementation and documentation services not only in India but overseas. We are familiar with all these issues and can help you implement & achieve ISO 13485:2012 Certification.

Area of operations

We are providing ISO certification services in Delhi, Faridabad, Ghaziabad, Gurgaon, Meerut, Aligarh, Sonipat, Panipat, Karnal, Moradabad, Lucknow, Kanpur, Patna, Baddi, Solan, Indore, Bhopal, Jaipur, Jodhpur, Ludhiana, Jalandhar, Ahmedabad, Vapi, Surat, Rajkot, Vadodara, Baroda, Pune, Mumbai, Bangalore, Kuwait, UAE, UK, USA, Canada and many more locations.