Cogmedix Certifications and Quality Policy
Cogmedix proudly bears certifications from a broad spectrum of respected international agencies:
- CE certification is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). CE marking is a key indicator of a product’s compliance with European Union Legislation .With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives. *(The CE marking is mandatory for certain product groups in the European Economic Area (EEA), consisting of the 27 Member States of the EU and EFTA countries Iceland, Norway, Switzerland and Liechtenstein. It is also obligatory for all products made in third countries (non-member states) which are sold in the EEA)
ISO 13485 certification quality management system and meet domestic and international regulations for medical device, while achieving overall business improvement.
TUV validates the safety of products of all kinds to protect humans and the environment against hazards. Certification involves rigorous testing of the applications for which the component is designed. It includes verification that the device satisfies the strictest European regulations for the industry in which the component was designed for and ensures the component specifications are stated correctly. Periodic retesting of the component is required to maintain TUV approval. The certification mark shows that manufacturer’s products have met applicable safety requirements and quality standards. When consumers see a TUV certification mark, they can be assured that they are buying a safe product that has been investigated to particular safety requirements by an accredited third party and is supported by regular surveillance audits.
- Canadian Standards Association (CSA) is a not-for-profit standards organization with primary activities that involve developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise producing technical standards that are intended to address the needs of some relatively wide base of affected adopters. CSA is a provider of print and electronic standards, related training and e-learning, as well as Advisory Services. CSA aims to develop standards for use in 57 different areas of specialization. CSA also tests products for the North American and International markets against applicable standards. Products that bare the CSA mark comply with all the standards set forth by the Canadian Standards Association.
- UL (Underwriters Laboratories) develops standards and test procedures for products, materials, components, assemblies, tools and equipment, chiefly dealing with product safety. UL also evaluates and certifies the efficiency of a company’s business processes through its management system registration programs. Products can be tested by the UL procedures to ensure that they are up to the correct safety standards. Having a UL certified product means that a it has passed all of the necessary tests and complies with all of the standards that are set forth by the Underwriters Laboratories. The way a product is constructed, the components it is made of, and the functions it performs are all major factors in obtaining a ULcertification.
- Restriction of Hazardous Substances (RoHS) holds electrical and electronic equipment companies directly responsible for the chemical compliance of their products. This means all products must conform to strict standards, provide extensive compliance documentation, and ensure that electrical and electronic products sold in the European Union do not contain lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ethers (PBDEs) above the legal threshold. Manufacturers, owners, retailers, and importers alike need to ensure that their products comply in order to be distributed and sold in the European Union.
- International Traffic in Arms Regulations (ITAR) is a set of United States government regulations that control the export and import of defense-related articles and services on the United States Munitions List. The U.S. Department of State interprets and enforces ITAR with the goal of safeguarding U.S. national security and U.S. foreign policy objectives. For practical purposes, ITAR regulations dictate that information and material pertaining to defense and military related technologies (for items listed on the U.S. Munitions List) may only be shared with U.S. Persons unless authorization from the Department of State is received or a special exemption is used. A company that complies with ITAR will act in accordance with all the regulations associated with ITAR.
- JCP (Joint Certification Program) establishes the eligibility of a U.S. or Canadian contractor to receive technical data governed, in the U.S., by DoD Directive 5230.25 and, in Canada, by the Technical Data Control Regulations (TDCR). Once a contractor has received JCP certification they will be able to access to unclassified technical data disclosing military critical technology with military or space application that is under control of the US Department of Defense or the Canadian Department of National Defense. Having this certification also allows contractors to access additional defense related business and government contracts.
- J-STD -001 denotes that a company meets all of the requirements for soldered electrical & electronic assemblies.