WHAT IS CE MARKING?
CE Marking Strategy for Medical Devices?
What products need the CE Marking?
The following products need CE marking:
Active implantable medical devices
In vitro diagnostic medical devices
Personal protective equipment
Simple pressure vessels
Radio and Telecommunications terminal equipment
Equipment and protective systems for use in explosive atmospheres
Explosives for civil use
New hot water boilers
Non-automatic weighing instruments
How to Get CE Mark Certification?
Low Voltage Directives
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.
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.
- 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.
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
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:
- Issue of Non-Conviction Certificate
- Issue of Performance Certificate
- Issue of Validity Certificate
- Issue of GLP Certificate
- 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
- License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device on Form MD-5
- 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
- Registration of FBO
- Product Registration
what is a medical device CE mark?
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.
There are some following steps of CE mark are as follows:-
- CLASSIFY AND ASSESS YOUR MEDICAL DEVICE
- SET UP A QUALITY SYSTEM (QMS) TO MANAGE YOUR MEDICAL DEVICE
- PRODUCE A TECHNICAL FILE TO MEET EU MDR ESSENTIAL REQUIREMENTS
- GO THROUGH AUDIT BY NOTIFIED BODY TO PROVE DEVICE CONFORMITY
- ANNOUNCE CONFORMITY OF MEDICAL DEVICE
- REGISTER WITH SUITABLE EXPERTS IN EUROPE
- SAVE THE DOCUMENTATION FOR FIVE YEARS
- ESTABLISH MONITORING SYSTEM
WHAT IS ISO CERTIFICATION?
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.