AQC is India based company that offers technical consultancy services to the healthcare industry (Medical Devices) manufacturing, testing laboratories.
The company has grown organically into the technical consultancy in the healthcare industry with offices at Delhi- NCR.

Thursday, 28 October 2021 / Published in MEDICAL DEVICE REGULATORY CONSULTANTS

MEDICAL DEVICE REGULATORY CONSULTANCY IN FARIDABAD

medical device consultant
AQC provides medical devices consultancy in India this is very helpful to all medical devices exporters and distributors.

Alpine Quality Consultant provides Consulting services for Medical Device Industry. Our Team of Experts incorporates Healthcare Professionals, Regulatory Compliance Consultants, and Doctors. We give our service in small possible time and cost-effective way.

MEDICAL DEVICE REGULATORY CONSULTING SERVICES

  • AQC provides all types of services regarding medical devices consultancy they all are helpful for all suppliers and distributors who are related to these consultancy services.
    Meeting with the right persons who are related to medical devices and giving the best consultancy regarding your work.

Alpine Quality Consultants give direction and support to compliances by qualified, experienced, and executive Advisors and Experts as for National and International Regulatory norms and rules. we support our customers to prevent and resolve compliances issues and also work on medical devices regulatory consulting.

We provide Solution Based Services for:

  1. Issue of Non-Conviction Certificate
  2. Issue of Performance Certificate
  3. Issue of Validity Certificate
  4. Issue of GLP Certificate
  5. Free Sale Certificate

License and Permissions as per MDR (Medical Device Rule) 2017

Testament of Registration for a Notified Body under the Medical Devices Rules, 2017 on Form MD-2

  • Advance License to Manufacture available to be purchased or for Distribution of Class A or Class B clinical device on Form MD-6
  • Permit to Manufacture available to be purchased or for Distribution of Class C or Class D on Form MD-9
  • Loan License to Manufacture available to be purchased or for Distribution of Class C or Class D medical device on Form MD-10
  • Permission to conduct Clinical Investigation on Form MD-23
  • Consent to lead a clinical exhibition assessment of new in vitro analytic medical device on Form MD-25
  • Permission to import or produce available to be purchased or for the distribution of a medical device that doesn’t have predicate medical device on Form MD-27
  • Consent to Import or Manufacture New In Vitro Diagnostic Medical Device on Form MD-29
  • Endorsement of test or assessment by the Central Medical Device Testing Laboratory on Form MD-31

FSSAI

  • Registration of FBO
  • Product Registration

what is a medical device CE mark?

AQC gives all knowledge regarding CE marking in medical devices consultancy.
CE Marking told the process of working and issuing this certification.

To sell medical devices in the European Union (EU), you should get or apply CE Marking for your item. CE Marking shows that your medical device conforms to the applicable EU guidelines and empowers the commercialization of your items in 32 European nations. As a legal medical device producer, you are liable for keeping up with regulatory compliance and securing CE marking for your item.

what is the step of the CE Marking process for Medical Devices?

Before the CE Mark might fasten to a medical device & sell within the European Union, the exporter must be following the rules like:-

1; Prepare Technical Documentation to show the item’s consistency with applicable fundamental requirements and confirm assessment systems of the material device.

2; Register their device with the legitimate Competent Authorities.

3; Receive a gadget express CE Certificate from a Notified Body.

8-Step Process

There are some following steps of CE mark are as follows:-

  1. CLASSIFY AND ASSESS YOUR MEDICAL DEVICE
  2. SET UP A QUALITY SYSTEM (QMS) TO MANAGE YOUR MEDICAL DEVICE
  3. PRODUCE A TECHNICAL FILE TO MEET EU MDR ESSENTIAL REQUIREMENTS
  4. GO THROUGH AUDIT BY NOTIFIED BODY TO PROVE DEVICE CONFORMITY
  5. ANNOUNCE CONFORMITY OF MEDICAL DEVICE
  6. REGISTER WITH SUITABLE EXPERTS IN EUROPE
  7. SAVE THE DOCUMENTATION FOR FIVE YEARS
  8. ESTABLISH MONITORING SYSTEM

WHAT IS ISO CERTIFICATION?

ISO standards are internationally agreed upon by experts Quality management standards to help work more efficiently and reduce product failures.
ISO certification is a certified endorsement from an outsider body that an organization runs to one of the international standards created and distributed by the International Organization for Standardization.

ISO certification ensures that a management system, invent the process, administration, or documentation strategy has every one of the requirements for standardization and quality confirmation.ISO (International Organization for Standardization) is an independent, non-administrative, global association that creates guidelines to guarantee the quality, security, and efficiency of products, administrations, and frameworks. Certification can be a helpful instrument to add believability, by demonstrating that your product or administration meets the expectations of your clients to an accredited consultant.

Type of ISO Certification

There are different sorts of ISO certificates accessible, for example;-ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, ISO 22301, etc.