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Medical Device

CE MARKING | FDA 510k | MDSAP | 21 CFR 820 | ISO 13485 | EU REP | TESTING






CE MARK | 510K | CFR 820/211/111 | EAR | CER | TESTING

Navigate the Medical Device Section (CE Marking, FDA & ISO 13485)

Medical Device CE Marking

What is CE Marking and why CE Marking for Medical products in the European market.

Classification of Medical Device

How the Medical Device are classified as per MDD ( CE Mark) requirement ? What are the different class of Medical Devices?

Technical File

The Technical File to be prepared for the Medical Device you are planning for CE Mark. It contains all the information relevant to

Notified Body

Why notified Body is required for CE Certification? How can we contact them and what is the fees ? How can we contact them?

CE Mark Consultants

What is the role of consultant? How they can help you with the CE Certification process. What will be the cost? How the consultants to be selected

Medical Device Export to USA

US FDA Registration and product listing is mandatory. How and what time the

Own-Brand Labelling ( OBL CE Certification)

What is OBL CE Certification? How to Certify? Who is OBL and who is OEM?

Testing of Medical Device

All medical products applying for CE Certification has to test the medical device as per Harmonized standards. How and where the test to be conducted? What are the test to be conducted

Software CE Marking

Software system that has been developed for the purpose of being incorporated into a Medical Device needs CE Logo

ISO 13485:2016

Why Implement ISO 13485 for CE Certification process? How can we implement ISO 13485? How long it will take and what will be the cost?

European (EU) Authorized Representative

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. It is required for all non european countries applying for CE Marking.

US FDA 510k

510(k) is a submission made to USFDA to demonstrate that the Medical Device to be marketed is safe and effective as others of similar intended use

21 CFR 820

This is a QMS / GMP requirement and to be implement by all the manufactures based on the product category. How long the process and what will be the cost

Navigate the Drugs, API & Cosmetics Section

World class Manufacturing Facility

How to set up world call manufacturing facility as per regulatory norms. What are the requirements? How a consultant can help.

US FDA Registration ( Drugs, API, Labs, Sterilizers)

Those interested to market Finished Formulations, API, Homeopathic Drug, Laboratory Service, should register with US FDA,s Centre for Drug Evaluation and Research (CDER).

NDC Labeller code (National Drug Code)

National Drug Code is a ten digit unique product identifier number for human drugs. How to get the number

US FDA Drug Listing

Listing to be done for all drugs planned to sell / Distribute in the United States of America. What is the procedure? How much to cost?

US Agent service (US representation services)

US FDA enforces the need for foreign-based Food, Drug and Medical Device companies without a location in the United States to register with the FDA after appointing a "U S Agent". How can we contact a US Agent? How much it will cost?

Drug Master File (US DMF)

A Drug master File is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. How a consultant can help? How much it will cost?

US DMF Submission Fees

Two activities involved are DMF preparation and US Agent Service. We can provide both services for all wishing to have DMF number from US FDA.

Drug Establishment Registration with FDA

FDA's Centre for Drug Evaluation and Research (CDER) is evaluating and approving new drugs before they are sold in the US. If your company is interested in selling prescription and non-prescription or over-the-counter (OTC) drugs

FDA Drug Registration and Listing

Domestic and Foreign drug manufacturing and distributing firms must at the time of drug establishemnt registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution

NDC Labeller code (National Drug Code)

NDC code request to FDA should submit in SPL (structured Product Labelling) format via FDA ESG (electronic submission gateway)

Navigate the Food and Nutraceutical Section

Export of food items to USA

Federal Food, Drug, and Cosmetic Act (FD&C act) and the fair Packaging and Labelling insists manufactures and importers to

US FDA Establishment registration

All food and nutraceutical exporters has to register with US FDA. Our consulting service helps to comply with FDA bioterrorism act requirements by?

Testing of Food

Test the product as per standard and make sure the safety and quality of the product

US FDA Facility Registration fees

We offer complete solution for US FDA registration with US Agent service. Our fees are very low

GMP / 21 CFR 110 requirements for US FDA

Code of Federal Regulations 21 CFR Part 110 requirements for Current good manufacturing practices (GMPs) for food manufactures

Acidified & Low Acid Canned Foods

Any commercial food manufacturer processing and packaging low-acid canned foods and acidified foods must register

Food Additives

A food additive is any substance added to food. directly or indirectly to becoming a component or otherwise affecting the characteristics of any food

FDA Certificate

Manufactures, Exporters and Traders across the globe are curious to have an FDA CERTIFICATE in the name of the company. But this is not possible. US FDA will not issue any kind of FDA Certificate to any kind of organization

US FDA Food Contact Substance (FCS)

Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down by violation to the act.

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