Friday, July 30, 2021

Types Of Cardiology Devices – Operon Strategist

 

Cardiology Devices comprise one of the largest categories of medical devices by sales. They are second only to in-vitro diagnostic devices. Approximately one out of every ten medical devices made are Cardiology Devices. Ranging from small, implantable devices to large external machines, they are used to diagnose and treat heart diseases and related cardiovascular problems.

Cardiology Devices perform a variety of functions. Some monitor the heart for arrhythmias, sometimes responding with actions to correct irregular beats. Others supplement the heart’s pumping action. Individual valves can be manufactured, as can artificial organs to replace the heart completely. 

Types of Cardiology Devices 

  • Implantable Cardioverter Defibrillators

People with advanced heart disease, heart failure and certain genetic arrhythmias are often at risk of life-threatening, fast, irregular heartbeats called ventricular arrhythmias. 

  • Pacemakers

There are two kinds of pacemakers. The traditional model is placed under the skin and connects to the heart via electronic leads. A smaller, leadless pacemaker is placed inside the heart and does not require transvenous leads.

  • Biventricular Devices

A biventricular pacemaker works like a conventional pacemaker but uses a third wire to send electrical impulses to the heart to resynchronize the contractions of the heart’s left lower chambers, or ventricles.Also called a cardiac resynchronization device, a biventricular pacemaker is implanted when medications don’t relieve symptoms of heart failure, a condition in which the heart does not pump a sufficient amount of blood to the body, and when the left chamber does not beat in a coordinated manner. 

  • Implantable Cardiac Loop Recorders

Your cardiac electrophysiologist may recommend implanting a wireless cardiac monitor called a loop recorder. This device continuously records information about your heart’s rhythm for up to three years.

  • Standards and Regulations for Cardiology Devices 

  • ISO 14708-1:2014 — Active implantable cardiac devices: general requirements for safety, marking, and information to be provided by the manufacturer.
  • ISO 14708-2:2012 — Cardiac pacemakers.
  • ISO 14708-5:2010 — Circulatory support devices.
  • ISO 14708-6:2010 — Particular requirements for active implantable medical devices intended to treat tachyarrhythmia.
  • ISO 27185:2012 — Cardiac rhythm management devices, symbols to be used with cardiac rhythm management device labels, and information to be supplied, and 5555general requirements.
  • IEC 62304:2006 — Medical device software.
If  You Want Medical Devices Services Consultation For Following.
  1. Medical Device Consulting 
  2. cdsco registration 
  3. FDA 510k Clearance 
  4. ce mark medical device 
  5. CDSCO Manufacturing License 
  6. CDSCO import license 
  7. TURNKEY PROJECT CONSULTANT 
  8. medical device manufacturing 
  9. iso 15378 certification 
  10. 21 cfr part 210 and 211 
  11. ISO 13485 Medical Device Consultant 
  12. Primary Packaging Turnkey Project Consultant 
  13. Clean Room Design Consultant 
  14. manufacturing site conceptualization 
  15. Market Analysis and feasibility for Medical Devices 
  16. manufacturing plant layout design 
  17. medical device design and development 
  18. DMF file submission guideline 
  19. 21 cfr part 820 
  20. qms certification services 
  21. capa management 
  22. design control requirements 
  23. medical device process validation 
  24. combination product 
  25. continuous improvement program 
  26. Medical Device Compliance & Regulatory Services 
  27. Cdsco India authorized agent for medical device   
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Tuesday, July 27, 2021

EU MDR FAQ - Operon Strategist

European Medical Device Regulation 

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The EU MDR faq will help you out with some queries and doubts about the regulation.

EU MDR faq as follows:

Why did the MDD need an update?

There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, software as a medical device (SaMD) did not yet exist. Software was something that controlled electric machines, and there were no apps that patients could use to monitor their own health. Demographics have also changed in Europe since 1992, with the population growing older, and there is a growing push for transparency of medical device technical information to the general public.

How is the new MDR structured?

The new MDR document is 174 pages in length. It contains a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). Compared with the MDD, which was 60 pages in length, the new regulations are much longer and more detailed.

What are the major thematic changes in the MDR?

Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a life-cycle approach to medical device regulation.While the old MDD essentially served as a manual for how medical device companies could get their CE marking and get to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the product lifecycle.

What Medical Devices are covered under the MDR?

The MDR defines the term “medical device” as an “instrument, apparatus, appliance, software, implant, reagent, material, or other article” that is used for any of the following:

Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention. Investigation, replacement, or modification of an anatomical, physiological, or pathological process. Providing data via in-vitro examination of samples derived from a human body

Will the MDR require enhanced device traceability?

Yes, it will. The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).

Read More  - EU MDR FAQ

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

Read More Article - 

If  You Want Medical Devices Services Consultation For Following.
  1. Medical Device Consulting 
  2. cdsco registration 
  3. FDA 510k Clearance 
  4. ce mark medical device 
  5. CDSCO Manufacturing License 
  6. CDSCO import license 
  7. TURNKEY PROJECT CONSULTANT 
  8. medical device manufacturing 
  9. iso 15378 certification 
  10. 21 cfr part 210 and 211 
  11. ISO 13485 Medical Device Consultant 
  12. Primary Packaging Turnkey Project Consultant 
  13. Clean Room Design Consultant 
  14. manufacturing site conceptualization 
  15. Market Analysis and feasibility for Medical Devices 
  16. manufacturing plant layout design 
  17. medical device design and development 
  18. DMF file submission guideline 
  19. 21 cfr part 820 
  20. qms certification services 
  21. capa management 
  22. design control requirements 
  23. medical device process validation 
  24. combination product 
  25. continuous improvement program 
  26. Medical Device Compliance & Regulatory Services 
  27. Cdsco India authorized agent for medical device   

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CDSCO Import License for Medical Devices In India

  Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vi...