Post Market Clinical Follow Up | Operon Strategist

Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This assessment and examination of clinical information relating to the medical device confirm the clinical security and execution of the device when utilized as by the intended manufacturer.

A study was done following the CE checking of a device and proposed to address explicit questions identifying with clinical safety or the performance that is the lingering dangers of a device when utilized as per its affirmed marking. The goal is to confirm that the clinical performance and safety all through the device lifetime, the adequacy of distinguished dangers and to recognize developing dangers, based on real-time data collection.

PMCF activities range from an extensive examination of information through existing device enrollments to conducting another new clinical investigation. European and American administrative prerequisites guidance the medical devices makers to consider the Post advertise clinical follow up as a feature of their Post Market Surveillance (PMS) Plan. Since clinical information accumulated in the pre-advertise stage might be too constrained to even consider identifying uncommon occasions or episodes. Post Market Clinical Follow-up is critical to recognize new and obscure risks and to encompass foreseen residual risks.

Circumstances, where a Post Market Clinical Follow up study, is indicated:

• Innovation or critical changes to the product
• High product-related hazard
• The severity of infection/treatment challenges
• Results from any past clinical examination
• Risks distinguished from the writing
• Unanswered inquiries of long – term security and execution
• Continued approval in instances of disparity
• Interaction with other medicinal products or treatment.

Post Market Clinical Follow – up Objectives

To meet MDR requirements, medical device manufacturers should design and run Post Market Clinical Follow up studies with main objectives:

• Confirming the device safety and its clinical performance
• Ensuring about continued acceptability of identified risks
• Detecting emerging risks on the basis of factual proofs

Post Market Clinical Follow – Up Design

• The extended follow-up of patients enrolled in premarket inspections
• A new clinical investigation
• A review of information obtained from a device registry;
• A review of related retrospective information from patients previously exposed to the device

Post Market Clinical Follow up studies must be outlined as a well – designed clinical investigation/Post Market Clinical Follow up Plan including:

• Clearly expressed research questions, targets and related endpoint
• Scientifically solid structure with a fitting basis and factual analysis plan
• A plan for conduct as per the suitable standard
• A plan for the inspection of the information and for making suitable determination.

EU MDR Requirements:

 Post Market Clinical follows up ought to be performed in accordance with a documented technique set down in Post Market Clinical Follow up plan.

The manufacturer will analyze the discoveries of the Post Market Clinical Follow up and document the outcomes in a Post Market Clinical Follow up evaluation report.    

Post Market Clinical Follow up plan must include some methods aiming of:

• Confirming about the security and execution of the device all through its normal lifetime.
• Identifying beforehand unknown side – impacts and look at about the recognized side – impacts and contraindications.
• Identifying and examining risks based on factual proof.
• Ensuring the continued with the acceptability of the risk-benefit ratio.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

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   

The Best Regulatory Pathway for Your New Medical Device

Regulatory Pathway

FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services, and also a federal executive department of the United States. The control and supervision is the responsibility of FDA for promoting public health and protecting of food safety, dietary supplements, vaccines, biopharmaceuticals, blood transfusions, medical devices, cosmetics, animal foods & feed and veterinary products. FDA announces a lot many plans that keep the safety and regulation in food and medical industry.

Amendments to the Federal Food Drug and Cosmetics Act in 1976 expanded the agency’s role to oversee safety in the development of medical devices. Medical Devices are regulated by the Centre for Devices and Radiological Health (CDRH) at the FDA. As Federal food, drug and cosmetic act are a set of laws and which gives authority to the US Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. According to the Federal Food Drug and Cosmetics Act, a device is “an instrument, apparatus, implement, machine, contrivance, implant or an in vitro reagent”.

So now, if a medical device manufacturer wants to get its product to market, the manufacturer has to determine the appropriate FDA classification of its medical device. As the medical device are classified whether your device fits into the Class I, Class II or Class III category. These medical devices are not classified based on your device design or the risk of the device but actually on “what your device will do” or “what your device is to be used for”.

Once the product (medical device) classification is done, now it’s time for premarket submission pathway, which is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. If your product is basically the same as a currently marketed medical device i.e. a predicate of your device, then you need to file a 510(k). Otherwise, if your device is Class III then the PMA process i.e. The Premarket Approval is the solution for you.

As discussed above the 510(k) i.e. pre-market notification and PMA i.e. premarket approval, are the two most common pathways for medical devices to market in the United States. And both pathways are divided into three different types. For 510(k) it has subtypes that are the traditional, special and abbreviated forms and for the PMA it is traditional, modular and streamlined.

At the increasing efficiency of the 510(k) process, the FDA intends to take several actions in the upcoming year that may create a great impact on the approval of the medical device pathway. FDA now plans and approves several guidance documents that are intended to create more detailed information regarding the FDA determinations.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

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