Quality management system Certification is required for every business process who need to comply with an arrangement of complex and challenging regulatory requirement. Hospaccx strategists with considerable expertise in regulatory areas required for QMS certification in implementation of Medical Equipment. It is very essential part for a Medical device company as is considered most basic part by ISO and FDA.
We provide the following consultation certificates for manufacturers:
- US FDA 21 CFR Part 820 Quality System Regulations: This process covers the facilities and control used for the design, manufacturing, packaging, labelling, storage, installations for Medical Equipment.
- ISO 13485 Certification: It is the world acknowledged standard by the International Standards Organization for medical device quality management system. It can be used by any company involved in the transfer of medical devices. This specifies the requirements for a QMS certification. ISO 13485 certification for medical devices is a Quality management system required for regulatory purposes which is an ISO standard. Thus, we help it for getting it for your Medical Equipment.
- ISO 9001:2015 is globally required standard to describe the requirements of a quality management system in all industries. ISO 9001:2015 provides effectual risk assurance-based Quality Management System.
Country Wise QMS certification include:
- US FDA 510k: This is a premarket approval made for FDA to signify that the device which is to be marketed is safe and effective. And also, which is substantially equivalent to the legally marketed device.
- DMF: Drug master file is a document that is prepared by the medical device makers or manufacturers in which they provide confidential information about the product to the US FDA.
- CDSCO: Central Drugs Standard Control Organization, CDSCO comes under DCGI that is Drug Controller General of India. CDSCO regulates the medical device in India, under the provisions of drugs and cosmetics acts 1940 & rules 1945. The Applications for all classes are submitted to Central Licensing Authority, where the DCGI takes the responsibility of Manufacturing, registration, import and sale of medical devices in India.
- CE marking: CE mark certification is regulatory approval for the European market. The products having a CE mark declares that the product which is to be marketed meets all the relevant European medical device directives. We’ll help to test the product, to the creation of the technical file, and resolving all the queries after completion of all the activities.
Hence, the QMS certification body and Medical Device agency professionals with in depth knowledge and technical expertise at Hospaccx can help you assist and protect your Quality System that can follow with the toughest regulatory inspection.
We therefore aim at making your Medical Equipment facility to get authorized and remain to the defined standards. The certification and approvals to a particular Medical device add on to a support to its quality and therefore defining it safety for usage.
