Thursday, October 24, 2019




Know how to Design Your Clean Room for Medical Devices





Clean room is a room built and maintained for that no dust, germs, bacteria or contaminants could enter inside. Clean rooms are generally pressurized, the pressurization is done by air pumps, or fans pumping air inside through a filter to prevent dust from getting inside. If any person opens the door or window the air goes out instead of the outside air coming in.
People working in a clean room have to wear protective garments or aprons to prevent any dust or contaminants tracked in. To enter inside everyone has to stand in front of air jets to knock off all the germs and dust. Clean rooms are almost found in any industry, which performs scientific researches or manufacturing and packaging of critical components.
A cleanroom plays a main and very important role in the productivity and features of medical device manufacturing. A cleanroom is a constrained environment that has a low level of impurities such as dust, airborne microbes, aerosol particles and chemical vapour.
Relying upon the clean room classifications personnel gowning should be limited as the laboratory coats and hairnets, or as broad as fully covered in the number of layered bunny suits with separate breathing equipment. Clean rooms generate coarse free air with the use of HEPA filter applying laminar or turbulent airflow principles.
Clean room design surrounds the whole air dispensation system, with the necessities for acceptable, downstream air returns. Depending upon how clean the air is clean rooms are classified. The cleanroom classification standards ISO 14644–4 needs specific crumb count and amounts and calculations to classify the cleanliness level of cleanroom and clean area.
  • Why do you require a clean room for manufacturing medical devices?
  • A cleanroom is a laboratory faculty generally used as a part of expertise industrial production or for scientific research which includes manufacturing of pharmaceutical items. Clean rooms are designed to control extremely low levels of particles such as pollutants, dust, etc. Clean rooms undergo a broad training of contaminants control theory.
  • What are the different classes for cleanroom?
  • Clean rooms are classified depending upon the cleanliness of the air in the rooms. Cleanroom classes are the amount of cleanliness the room follows with, as per the size and amount of particles per volume of the air. Clean rooms are laboratory faculties used for industrial production used for manufacturing of the medical or pharmaceutical items.
Clean rooms are ordered by how clean the air is. In ISO- 14644-1, the number of particles equivalent to and more noteworthy than 0.5mm is estimated in one cubic foot of air, and this check is utilized to group the spotless room.
Read More -  Design Your Clean Room for Medical Devices

Contact details –


Phone no -  9325283428

Mail  - dm@operonstrategist.com
If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 

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Risk management system for medical devices should be up to date

The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management ISO 14971 for medical devices and steps to implement it during the product development stage.
ISO 14971 an international standard for risk management related to the manufacturing of medical devices. It is recognized by most regulatory authorities as the “de facto” standard for risk management. ISO 14971 is an integral part of an effective quality management system and should be embedded into your medical device manufacturing life-cycle process. A solid risk assessment program helps you identify design issues before distribution, eliminating dangerous problems and the costs associated with recalls.
Medical device companies MUST have established risk management processes that comply with ISO 14971.
And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. Every international regulatory agency you’ve ever heard of accepts ISO 14971, as the risk management standard for the medical device industry. ISO 14971 is a good standard. Informative and descriptive. Easy (enough) to comprehend.

Contact details –


Phone no -  9325283428

Mail  - dm@operonstrategist.com
If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing
    2.     CDSCO Registration
    3.     FDA 510 k clearance
    5.     Design Control Requirements
    6.     QMS Certification Services
    8.     Primary Packaging Consultant
    9.    CE Marking Consultant 

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Wednesday, October 16, 2019

The demand of Medical Devices in Indian Healthcare sector


The demand of medical devices in India has been permitted by 100 % FDI by means of programmed course in the clinics and in the medical devices sectors. Indian medical history has watched a climb significantly.  To turn into an industry head and increase an edge over the contenders the makers in the medical services segment need to enter the business sectors deliberately while shuffling with the elements of the targeted audience.
The Demand for medical devices and the Indian healthcare sector has developed a lot in the course of the most recent 10 years. In any case, precisely what is a medical device or medical technology? For any technology that broadens and improves life, and mitigates torment, damage and impairment fall under medical technology.     
The healthcare sector is the 4th biggest sector, with hospital clinics and medical devices representing 91% of the total market. The Indian medical industry comprises of enormous multinationals that have broad assistance systems and little to medium ventures. India’s medical innovation can be distinguished as a dawn division with significant government centre around its improvement the segment is relied upon to contact USD 9.6 billion in the year 2022.
Operon Strategist provides complete turnkey project consulting right from facility layout to system implementation, we’ll help you for the CDSCO licensing process and also for the FDA 510k clearance and premarket approval and make the long process easy and smooth.
The demand of the medical devices market is significantly determined by the components, for example, the rising number of surgeries with rising commonness & incidence of different incessant infections of different and expanding ageing population. Also expanding human services use, expanding request of plastic and reconstructive medical surgery and rising interest for technologically progressed insignificant obtrusive surgeries are additionally expected to support the market development during the forecast period.
Review of Medical Device Industry:
The Indian medical market is developing relentlessly. As India’s social scene and medical services advance, its medical devices market rises as a promising open door for remote producers.

Read More - Demand Of Medical Devices

Contact details –
Phone no -  9325283428
Mail  - dm@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   



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FDA 21 CFR part 820 and iso 13485


Get to know the importance of the difference between FDA 21 CFR part 820 and iso 13485



FDA 21 CFR part 820 and iso 13485 :

Through the span of over 20 years in regulatory affairs and quality consistency, we’ve figured out how difficult it very well may be to actualize a quality administration framework that successfully empowers effective item advancement while conforming to both residential and international quality framework requirement. However, it is important to clarify the differences and the consequences of these in the actual work field hence, let’s have a glance at their differences in Quality system regulation.

What is 21 CFR Part?

FDA 21 CFR Part 820 aka the Quality system regulation highlights current good manufacturing practices (CGMP) regulations that control the techniques used in, and the provision and controls used for, the manufacture, design, labelling packaging, installation, storage as well as servicing of all finished devices. manufactured for human use.
These needs are meant to meet to ensure that medical devices are effective and safe.  Device manufacturers go through FDA inspections to make assure FDA 21 CFR 820 Compliance.

What is  ISO 13485?

ISO 13485 determines necessities for a quality management framework where an association needs to exhibit its capacity to give medical devices and related administrations that reliably meet client and relevant regulatory prerequisites.
Such associations can be engaged with at least one phases of the life-cycle, including outline and advancement, generation, stockpiling and dispersion, installation, or adjusting of a medical gadget and plan and improvement or arrangement of related exercises (e.g. specialized help). ISO 13485:2016 can likewise be utilized by providers or outside gatherings that give the item, including quality management framework related administrations to such associations.

Where do they apply?

  • ISO 13485 identifies as a global standard that is not mandatory in the US however mandatory in some countries. CB’s plan audits to assure conformance.
  • The FDA enforces 21 CFR 820
  • 21 CFR 820 is associated with medical device manufacturers of finished devices sold in the US, along with imported products. Some parts of the requirement might apply and this also depends on the medical device class.

The relationship between ISO 13485 And 21 CFR Part 820

They have a few contrasts, which is the thing that has shielded them from blending. ISO 13485:2003 is a standard in view of ISO 9001 that is particular to restorative gadgets. This standard isn’t received by the Food and Drug Administration (FDA) yet the FDA took part in composing ISO 13485:2003 to ensure their prerequisites and ISO 13485:2003 are adjusted. The FDA QSR has more stringent dissension handling and announcing prerequisites. But, if a company meet up with the prerequisites of ISO 13485:2003, then they should simply able to match the FDA quality system requirements.

Read More - Difference between FDA 21 CFR part 820 and iso 13485


Read More Article - 

1. Orthopedic Implants Manufacturing
2. Dental Implants Manufacturing
3.Blood Collection Tubes Manufacturing
4. How to start the Manufacturing of Disposable Syringes?

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   

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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...