CRITICAL STEPS TOWARDS ISO 13485 CERTIFICATION
Most medical equipment manufacturing companies are guided by GQS consultants and ISO certification body regarding the requirements to be implemented and complied to.
The statutory and regulatory requirements applicable for medical equipments have to be studied, reviewed and documented before the documentation kick starts. There are over 30 documented procedures and documents needed to roll out the same for implementation.
For these 30 documented procedures, mandatory records over 40 have to be implemented by various departments.
Clinical validation, Clean room validation, Advisory notices, Servicing instruction, Installation instruction, Technology handover post design, Risk assessment based on ISO 14971 covering all harms associated with the use of medical equipments have to be reviewed, documented and implemented.
During Design of these medical equipments, it is important to understand if there are samples or information from patients used are controlled and complied as per the latest EU regulation against Data Protection. The articles and recitals of the 99 GDPR Articles have to be studied and complied.
Should you require further information on ISO 13485 Consultants, ISO 13485 Certification, ISO 13485 Consultancy drop us an email at SHAKTI@GQSINDIA.COM
Call us 9845313910 / 9845078743
With the launch of Medical Product Regulations since 2017, all medical products falling under
CLASS 1, CLASS2 and CLASS 3 shall have to undergo certification to Quality Council of India QCI accredited ICMED Indian Certification for Medical devices.
The legal requirements will be in force w.e.f 2018 and shall comply to all the specifications and requirements for factories manufacturing, trading or supplying medical products falling under CLASS 1, CLASS 2 or CLASS 3 type.
QCI has launched ICMED in 3 categories for certification
All organisations supplying, trading or manufacturing have to mandatorily achieve certification by QCI accredited Notified body.
GQS was one of the first to attend major seminars on this subject and has been in the field of Medical product certification since 2001 and registered by QCI since its inception.
Drop in an email to SHAKTI@GQSINDIA.COM or RAJ@GQSINDIA.COM to know more details about ICMED, QCI, Certification, Consultancy, ISO 13485.