Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
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Medical Device Certification Consultant

Leading Service Provider of us fda 21 cfr part 820 quality system regulation, gmdn number assessments service, ce marking consultant, cdsco wholesale registration, iso 13485 consultant for medical devices: and 510(k) clearance & premarket approval from Pimpri Chinchwad.

US FDA 21 CFR Part 820 Quality System Regulation

US FDA 21 CFR Part 820 Quality System Regulation
  • US FDA 21 CFR Part 820 Quality System Regulation
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Approx. Price: Rs 1 / UnitGet Latest Price

Service Details:

Minimum Order Quantity2 Unit
Industry to CaterHealthcare

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). 

US Govt. give flexibility of QS regulation . this regulation does not prescribe in detail about how a manufacturer must produce a specific device Rather, the regulation provides the framework that all manufacturer must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

                During inspections, FDA will assess whether a manufacturer has

established procedures and followed requirements that are appropriate

to a given device under the current state-of-the-art manufacturing for

that specific device.

 Operon will help you to maintain the system as per regulation,provide service for implement system and documentation and guide for testing requirement.

For more visit www.operonstrategist.com

Operon Strategist does an initial gap analysis of the existing system to determine the extent of development of the quality system.

We guide the clients through documentation & help them to effectively implement it through the various functions of the company.

We also conduct a mock audit to test the effectiveness of the implementation of Part 820 requirements. We also provide post-inspection guidance to clients to help them close any non-conformance observed during the audit.

21 CFR Part 820 - FDA Quality System Regulation

Are you prepared to sell your medical devices in the United States? Provided that this is true, your organization must conform to the US FDA Quality System Regulation (QSR), particularly known as 21 CFR Part 820.

 

Regardless of the possibility that you as of now have a quality management system must meet this regulation before you can sell your device.

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GMDN Number Assessments Service

GMDN Number Assessments Service
  • GMDN Number Assessments Service
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Service Details:

Minimum Order Quantity1 Unit
Preferred LocationIndia
Type of Service Provider Service Cosultant
Type of Service ContractProject Based

GMDN Number Assessments Service offered is handled by experienced industry professionals who have with them rich process experience so as to assure delivery of quality and solutions. The Global Medical Device Nomenclature solutions offered comprises an international system which is used for identifying as well as classification of medical devices as well as support distinguishing one type of medical device from another.

Some of its features include:
  • Allow medical devices with similar features to be identified
  • Used for assisting consistent assessment of medical devices before getting approved for supply
  • For exchanging post-market vigilance information between regulatory bodies
  • Services support clients in updating database in alignment with technological advancements
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CE Marking Consultant

CE Marking Consultant
  • CE Marking Consultant
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Service Details:

Type of CertificationNew Certification
Type of IndustryIT and Consulting
Type of Service ProviderIndividual Consultant
Mode Of ReportHard Copy

The CE Mark is a conformity mark which all medical devices must have before they can be marketed.It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact with the body & ; the duration of contact.

Our Service range includes CE Mark certification consultancy services. CE marking – In order to market products in the European market, the products must have a CE mark which declares that a product meets the EC directives.

Experienced industry professionals  are handled CE  Requirement services by  who have necessary knowledge as well as in depth knowledge of meeting the demands of CE Mark Certification.

Our team supports clients in meeting “European submission” standards that declares the product offered is in compliance with Essential Requirements of relevant European safety, health and Environmental protecting regulation.

We Are Leading Medical Device CE Marking Certification Consultant Serviceprovider for Medical Device disposable implant Manufacturers , Medical Disposable syringe Manufacturers , Medical Devices and Surgical Instrument Manufacturers , Orthopadic Implant &instruments Manufacturers , Laboratory Equipment Manufacturers , Sterilization Equipment and Accessories Manufacturers,Medical Imaging systems Manufacturers

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CDSCO Wholesale Registration

CDSCO Wholesale Registration
  • CDSCO Wholesale Registration
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Service Details:

Type of ServiceNew company registration
Type of OwnershipPartnership
Company TypeIndustrial
Mode Of ServiceOnline

The Medical device industry in India is regulated by Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs &Cosmetics Act 1940 & Rules 1945.

The CDSCO is responsible for regulating the registration & sale of notified medical devices in India.

We also help companies get the wholesale license to facilitate sale of their products in India.The Central Drugs Standard Control Organization (CDSCO)is the national regulatory body for Indian pharmaceuticals & medical devices.

The Central drug standard control organization (CDSCO) is the national regulatory body or licensing authority for Indian pharmaceuticals and medical devices.

CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. The headquarter of the Central Drugs Standard Control Organization is located at New Delhi.

CDSCO has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country.

Medical Device Registration and CDSCO approval process In IndiaStep 1:

Is your product on the list below of Notified Medical Devices and IVDs which require device registration in India? Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, IV Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAG and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes.

Step 2:

For medical device or IVD on list above, appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license (Forms 20B and 21B).

Step 3:

For medical device or IVD on list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.

Step 4:

For medical device or IVD on list above, file application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations.

Step 5:

For medical device or IVD on list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.

Step 6:

For medical device or IVD on list above, obtain Registration Certificate Form 41 from CDSCO. Certificate is valid for up to 3 years.

Step 7:

Identify your distributor in India (holding forms 20B and 21B).

Step 8:

Apply for Import License using Forms 8 and 9 available from CDSCO. You must identify your chosen distributors on these forms.

Step 9:

btain Import License (Form 10) from CDSCO. License valid for 3 years.

Step 9:

You are now authorized to market your device in India.

Related Projects:

 

Name:CDSCO Import License & Wholesale Registration
Year: 2006
Type: Got it

 

Name: ISO 13485 Consultant 
Year: 2008
Type: Got it

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ISO 13485 Consultant for Medical Devices:

ISO 13485 Consultant for Medical Devices:
  • ISO 13485 Consultant for Medical Devices:
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Service Details:

Type of CertificationNew Certification
Type of IndustryIT and Consulting
Type of Service ProviderIndividual Consultant

ISO 13485 is a quality management system specifically developed for medical devices & related services. ISO 13485 can also be used by suppliers or external parties that provide the product, including quality management system relatedservices to such organizations.

Operon Strategist helps clients develop, implement & maintain an efficientquality management system. We do an initial gap analysis of the existing system to determine the extent of development of the quality system.

We Are Regulatory Project Consultant Service provider for Medical Device disposable implant manufacturers, Medical Disposable syringe manufacturers , Medical devices & surgical  instrument manufacturers,Orthopadic Implant Design Consultant , laboratory equipment manufacturers Sterilization Equipment and Accessories Manufacturers medical imaging systems manufacturers.

ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the designand manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system -related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirementsapply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

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510(k) Clearance & Premarket Approval

510(k) Clearance & Premarket Approval
  • 510(k) Clearance & Premarket Approval
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Service Details:

Minimum Order Quantity1 Unit
Type of Service ContractRetainer Based
Type of IndustryManufacturing
Type of Service ProviderConsulting Firm

510(k) Clearance & Premarket Approval

In US, the US FDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices, there is establishment & registration & device listing.

Operon Strategist classifies the devices & gathers information about the company the products which is then uploaded through an online process.
For class II devices, there is a process called the 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.

A 510(k) is a premarket submission made to FDA to show that the device to be advertised is at least as safe and effective, 510(k) implies it is considerably equivalent to a legally marketed device and isn’t liable to PMA.

The legally marketed device(s) to which comparability is drawn is normally known as the “predicate.” Although devices recently cleared under 510(k) are regularly chosen as the predicate to which equivalence is guaranteed, any legitimately marketed device might be utilized as a predicate.

USFDA Medical Devices 510(k) File Submission
Operon Strategist helps client in classification of the device after consultation with the client. Thereafter, the 510(k) process is explained & the scope of work is explained. After conferring with the client, we establish the predicate device & testing requirements as per US FDA

consensus standards. We help in compilation of the 510(k) file, review of test reports, and submission of the file to US FDA & correspondence with US FDA.

We also help in handling the queries raised by the US FDA reviewer. We support the client until they receive the 510(k) clearance letter.

The 510(k) is Required For

Domestic manufacturers introducing a device to the U.S. market.

Repackers or relabelers who make labeling changes or whose operations significantly affect the device.

Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

A Manufacturer needs 510k when:

Anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

Change in the intended use for a device which you already have in commercial distribution.

If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.

A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use.

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Anil Chaudhari (Proprietor)
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway Morwadi, Pimpri Colony
Pimpri Chinchwad- 411018, Maharashtra, India



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