ISO 13485
ISO 13485:2016Â specifies the requirement of Quality Management System of Medical devices/equipment that consistently meet the Customer and applicable regulatory requirement.
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/equipment.
​
ISO 13485 is generally harmonized with ISO 9001 and the basic difference is that ISO 9001 requires Organization to demonstrate continual improvement whereas ISO 13485 requires an Organization to demonstrate the quality management system for medical devices is effectively implemented & maintained.
Grow Your Business
ISO 13485 focus on:
The promotion and awareness of regulatory requirements as a management responsibility. ​​
Controls in the work environment to ensure product safety.
Focus on risk management activities and design control activities during product development.
Specific requirements for inspection and traceability for implantable devices.
specific requirements for documentation and validation of processes for sterile medical devices.
Specific requirements for verification of the effectiveness of corrective and preventive actions.
​
​The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices. In addition, compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
HOW CAN CARI CONSULTANCY ASSIST YOU?
Cari Consultancy provides ISO 13485 system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
​
We use the following consultation approach to assist you in achieving certification:
Identify areas requiring improvement or development within your current Management System
Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
Provide assistance and advice on the development and implementation of systems, including preparation of documentation
Advise and assist, if required, with the preparation and submission of applications to your certification body
Assist with the development of internal auditing procedures and training
Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
SEND US AN ENQUIRY
Send us an enquiry by filling form below, we will get back to you as soon as we can.
No. S-7, Gamuda Biz Suites, Persiaran Anggerik Vanilla, Kota Kemuning, 40460 Shah Alam, Selangor