CE Mark
CE marking. The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the European technical regulations (“Directives”), related to European health, safety and environmental protection legislation, and that the product compliance has been established using the appropriate
CE marking is a crucial procedure that guarantees a product’s conformity to EU regulations. … Selling products without the CE marking is an economic offense that is sanctioned differently by each Member State of European Union. Affixing CE marking on products that do not require the CE marking can also lead to penalties.
We can help you gain access into the European market by ensuring your product meets all CE marking requirements.
CE marking allows you to legally market and distribute your product within the European Market, and declares that your product complies with all applicable European Directives and Regulations.
We work with organizations as a consultant, helping you to understand and comply to the essential requirements, and enabling you to confidently and legally affix CE marking to your products.
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PRESSURE EQUIPMENT DIRECTIVE (PED) 2014/68/EU
The Pressure Equipment Directive (PED) is European Legislation aimed at removing the technical barriers to trade relating to the supply of pressure equipment throughout Europe. The PED is based on Essential Safety Requirements (ESRs) that govern design, manufacturing, inspection and testing.
The PED offers manufacturers of pressure equipment 14 different conformity assessment options which permit the pressure equipment manufacturer to demonstrate compliance by variants on Quality Assurance, Direct Inspection or Surveillance of Testing offered by the Notified Body.
- Assistance with technical file preparation
- PED compliant quality system preparation
- Gap analysis visits.
- Assistance in Comply with applicable Product based Technical Standard.
- Specially arranged training courses
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Indian Boiler Regulation (IBR)
The Indian Boiler Regulation (IBR) defines standards for product design and construction as well as inspection and testing methods. The IBR requires that an inspection company approved by the Central Boiler Board (CBB) must certify all pressure equipment using steam.
What is IBR Approval?
Incorporation by reference (IBR) allows Federal agencies (you) to comply with the requirement to publish rules in the Federal Register and the Code of Federal Regulations (CFR) by referring to material already published elsewhere.
How to get an IBR certificate?
Learn more about the process of getting equipment certified to the Indian Boiler Regulations (IBR).
- Design review.
- Material inspection.
- Stage testing.
- Welder certification.
- In-service inspection and certificate renewal.
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US FDA
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA approval is important, because it validates the need for research on how drugs work on children, not just adults. It also allows us the properly determine the appropriate dosage for children, determine the best route of administration, and test for any drug interactions.
To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.
Phases of Drug Development
- Phase I: Discovery & Development.
Phase II: Preclinical Research.
Phase III: Clinical Research.
Phase IV: FDA Review.
Phase V: FDA Post-Market Safety Monitoring.
“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.
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