AQC gives all knowledge regarding CE marking in medical devices consultancy.
Wednesday, 01 December 2021 / Published in CE MARK CERTIFICATION

CE MARK CERTIFICATION FOR MEDICAL DEVICE

AQC gives all knowledge regarding CE marking in medical devices consultancy.

CE Marking told the process of working and issuing this certification.

WHAT IS CE MARKING?

CE stands for Conformité Européenne, which translates from
French to English as ‘European Conformity.CE Mark Certification indicates
that a product has been assessed by the manufacturer and deemed
to meet EU(European Union’s) safety health and environmental
protection requirements.CE mark mandatory conformity marking
for regulating the products sold within the European Economic
Area (EEA) since 1985. It is needed for products manufactured
anywhere inside the world that is then marketed inside the EU(European Union’s).

CE Marking Strategy for Medical Devices?

To sell medical devices inside the European Union (EU), you must get or apply CE Marking to your product. As a Medical Device Software manufacturer, no matter whether you outsource the producing technique, you are responsible for acquiring the CE marking. In popular, the path towards acquiring the CE marking depends on the medical device’s class. Since in the light of the EU, MDR Medical Device Software is taken into consideration as an active medical device, it belongs at least to magnificence IIa MDR Medical Device Software is taken into consideration as an active medical device, it belongs at least to magnificence IIa.

What products need the CE Marking?

No. CE marking is compulsory for the greatest products protected by using the New Approach Directives. The process of establishing whether or no longer a product requires CE Marking is particularly complicated. Manufacturers want to set up.CE marking shows that the product meets sure statutory requirements connected with things like safety, health, and the environment.

The following products need CE marking:

  • Medical devices
  • Active implantable medical devices
  • In vitro diagnostic medical devices
  • Construction products
  • Machinery
  • Electronic equipment
  • Personal protective equipment
  • Pressure equipment
  • Simple pressure vessels
  • Gas appliances
  • Radio and Telecommunications terminal equipment
  • Lifts
  • Cableways
  • Equipment and protective systems for use in explosive atmospheres
  • Explosives for civil use
  • New hot water boilers
  • Measuring Equipment
  • Non-automatic weighing instruments
  • Toys
  • Recreational craft
The following product categories do not require CE Marking;
  •  Cosmetics
  • Foodstuffs
  • Chemicals
  • Pharmaceuticals

How to Get CE Mark Certification?

First, we identify what directives are applied. this may include;
  • Electromagnetic Compatibility
  • Radio Equipment
  • Low Voltage Directives
CE Marking requires EMC checking for electronic and electrical products,

Steps in CE Marking;

  • Decisions whether a product is a medical device and by which of the European medical devices directives it is covered.
  • Identify the applicable harmonized standards.
  • Classification of the devices by the manufacturer.
  • Contact to Notified Bodies, Preliminary discussions, and exchange of information, choice of the notified body.
  • Answering specific questions of the chosen notified body, confirmation of device classification bt the notified body, time and cost estimation for different certification routes; choice of the certification route by the manufacturer.
  • Formal application and certification contract.
  • Submission and Evaluation of documents to the notified body.
  • Audit of the manufactures’ operations and if applicable and required also suppliers and/or subcontractors’ facilities including reporting D.
  • The decision about the certification and issuing of the relevant certificate(s), which are usually valid for five years.
  • Surveillance audits.
  • Full re-audit and issuing of new certificates normally after five years.

We will manual you in Six Steps towards the successful Certification of your product.

Your intention is to finish the Certification process and affix the CE marking to your product. Thus, what you want is a clear outline of the necessary steps and the most qualified professionals by using your side.  Depending on the product category, the course of action for acquiring a CE certificate varies. Yet, the basic process follows these steps:
  • Check which EU Directives apply for your product.
  • Search for essential requirements for your product.
  • Determine if the product requires Notified Body evaluation.
  • Assess product conformity.
  • Draft and maintain technical files.
  • Draw up the Declaration of Conformity and affix the CE marking in all products.

 

 

 

 

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.