-Operon Strategist provides ISO13485 consulting service for medical device manufacturers. ISO 13485 is a quality system standard designed for medical device companies. Getting ISO 134485 certification gives manufacturers an upper hand in the competitive market. It is especially beneficial for manufacturers looking to export to Europe as one of the requirements for obtaining CE mark is complying with the ISO 13485 standard. We have guided various clients in USA, Europe, Australia as ISO 13485 consultants.
Benefits of ISO 13485 certification:
*Consumer Satisfaction – Production & supply of products that reliably meet consumer requirements as well as quality, safety and legal requirements.
*Decreased working costs – through constant change of procedures and improvements in operational efficiencies
Better regulatory control & understanding of various components along the supply chain including employees, consumers, vendors, distributors & suppliers
*Legal Compliance - regulatory requirements impact the organisation and its customers.
*Improved risk management - through more prominent consistency and traceability of items and utilization of risk management technique.
Our services include:
1. Gap analysis of existing system
2. Guidance for documentation as required by ISO 13485
3. Training & implementation
4. Assistance during audit
5. Guidance for complying with audit queries.
Website:www.operonstrategist.com Contact No:+91-9823283428
Benefits of ISO 13485 certification:
*Consumer Satisfaction – Production & supply of products that reliably meet consumer requirements as well as quality, safety and legal requirements.
*Decreased working costs – through constant change of procedures and improvements in operational efficiencies
Better regulatory control & understanding of various components along the supply chain including employees, consumers, vendors, distributors & suppliers
*Legal Compliance - regulatory requirements impact the organisation and its customers.
*Improved risk management - through more prominent consistency and traceability of items and utilization of risk management technique.
Our services include:
1. Gap analysis of existing system
2. Guidance for documentation as required by ISO 13485
3. Training & implementation
4. Assistance during audit
5. Guidance for complying with audit queries.
Website:www.operonstrategist.com Contact No:+91-9823283428
