ISO 13485:2013 Consultants
ISO 13485 certification India
Devices used for medical purposes should be manufactured with great care and safety to avoid any hazards that could be caused to patients. ISO 13485 Certification is one of the certification that sets requirement for a comprehensive and integrated quality management system to be complied by manufacturer of medical devices and some pharmaceutical companies. Introduced by international organization for standardization ISO 13485 Certification is considered very critical for success of an organization.
Compliance with ISO 13485 ensures compliance with European regulatory requirements. Hence any product that is not certified with ISO 13485 Certification is ineligible for sale in European countries.
OHSAS 18001:2007 Certification India
ISO 13485 Certification is an extension to ISO 9001 except requirements as to customer satisfaction are not present in former.
Following are ISO 13485 certification requirements to be adhered
- It calls for certified organization to demonstrate that quality system is effectively implemented and maintained.
- Validation of effectiveness of preventive and corrective actions.
- Documentation of all the process for sterile medical devices
- Inspection of implantable devices.
- Risk management activities during product development
- Design control activities during product development
- Control measures to be installed to ensure product safety.
It is prudent that no rational man would ever buy medical products that he has doubt as to its safety because of the fact that consequences of using those products could be dire. ISO 13485 Certification helps building trust among customers that product is safe to use. Getting ISO 13485 Accreditation has many benefits for organization.
Following are some of the advantages for organization opting for ISO 13485 Certification-
- It helps in compliance with European regulatory requirements
- ISO 13485 Accredited units are able to get more business as compared to other firm.
- It ensures safety of medical devices.
- ISO 13485 Certification helps in getting more business across the world.
- It helps in gaining customer trust and maintains good customer relationship.
- ISO 13485 Certification improves quality of goods to be produced.
- It helps in saving cost along the production chain.
We as ISO 13485 Certification Consultant help business organization avoid these penalties. GMPCERTIFICATIONINDIA has good experience of serving clients and helping them in getting ISO 13485 Certification. We understand the whole process of getting ISO 13485 Certification and thus help our client in cutting cost and saving their valuable time.
ISO 13485:2013 Certification & Consultants Delhi - India
We entertain clients from everywhere in the city notwithstanding with their size, location and type of the business.
ISO 13485:2013 Consultants by State