ISO 13485:2016 Certified
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s lifecycle, including service and delivery.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 9001:2015 Certified
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. These quality management principles include customer focus, leadership, engagement of people, process approach, improvement, evidence-based decisioning and relationship management.
FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured in the United States. The FDA also inspects and enforces regulations related to these industries. Organizations that manufacture, re-pack or re-label products in the aforementioned industries must register with the FDA.
IPC-A-610E, 620 Class I, II Compliant
IPC classes, with regard to the Assembly Standard 610 are used to standardize the acceptability levels of electronics. The standard is a tool to establish a level of quality and communicate quality acceptance criteria across the industry. The secondary purpose, for a company like Versa Electronics, is to ensure we understand the cost and inspection controls needed to support customers. What might be a ‘process indicator’ to one customer is a ‘defect’ to another customer. The standard level of control is best defined with IPC 610 Assembly Standardization.
IPC Corporate Member
Since 1957, IPC has been guiding the electronic interconnection industry through dramatic changes. IPC is the only trade association that brings together all of the players in this industry: designers, board manufacturers, assembly companies, suppliers, and original equipment manufacturers. As a member-driven organization and leading source for industry standards, training, market research and public policy advocacy, IPC supports programs to meet the needs of an estimated $2 trillion global electronics industry.
SMTA Corporate Member
The Surface Mount Technology Association (SMTA) is a non-profit international association of companies and individuals involved in all aspects of the electronics industry. The Association is dedicated to the advancement of the electronics industry through member education and interaction.
Apple MFi Developer Licensed
Apple Inc.’s MFi Program (“Made for iPhone/iPod/iPad”) is a licensing program for developers of hardware and software peripherals that work with Apple’s iPod, iPad and iPhone. The name is a shortened version of the original long-form Made for iPod.
CSA Regulatory Compliance
Canada: CSA certification CSA Group has the largest subject area recognition of the SDOs accredited by the Standards Council of Canada (SCC), an organization that coordinates Canada’s National Standards System. We maintain our accreditation by developing consensus standards that adhere to the requirements established by the SCC.
United States: CSA Group is accredited by the American National Standards Institute (ANSI), an organization that coordinates the standards strategy for the U.S. We maintain ANSI accreditation by developing consensus standards that comply with ANSI Essential Requirements.
TÜV (Technischer Uberwachungsverein) is of German origin, translated as the Technical Inspection Association. TÜV is the leading and the most competent provider of product testing and certifications for the worldwide marketplace.
The ETL, Edison Testing Laboratories, Listed Mark is proof of product compliance (electrical, gas and other safety standards) to North American safety standards. Authorities Having Jurisdiction (AHJ’s) in 50 states and Canada and retailers accept the ETL Listed Mark as proof of product safety. Manufacturers are choosing ETL certification because it gives them a competitive advantage in the marketplace. Today, the ETL Listed Mark is featured on millions of products sold by major retailers. The product with ETL extract transform Listed Mark from certified by ITS. This certification mark indicates that the product has been tested to and has met the minimum requirements of a widely recognized U.S product safety standard, that the manufacturing site has been audited, and that the applicant has agreed to a program of periodic factory follow-up inspections to verify continued performance.
UL (Underwriters Laboratories)
If a product carries this Mark, Underwriters Laboratories found that samples of this product met UL’s safety requirements. These requirements are primarily based on UL’s own published Standards for Safety. This type of Mark is seen commonly on appliances and computer equipment, furnaces and heaters, fuses, electrical panelboards, smoke and carbon monoxide detectors, fire extinguishers and sprinkler systems, personal flotation devices like life jackets and life preservers, bullet resistant glass, and thousands of other products.
FCC (Federal Communications Commission)
The Federal Communications Commission (FCC) is an independent United States government agency that is directly responsible to Congress. The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite, and cable. The FCC’s jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions. All devices that operate at a clock rate of 9 kHz are required to test their product to the appropriate FCC Code.
RoHS Directive (2011/65/EU) aims to reduce risks to human health and the environment through the replacement of certain substances in electrical and electronic equipment through less hazardous alternatives or technologies. RoHS restricts the contents of these substances in electrical and electronic equipment.
The new European Chemicals Regulation REACH (Regulation European Community 1907/2006) was entered into force June 1, 2007. REACH concerns Registration, Evaluation, Authorization, and Restriction of Chemicals. It affects most industries. The aim of the regulation is to guarantee a high safety level for health and environment. All substances produced in or imported to EU, in amounts exceeding 1 tonne annually, require registration at European Chemicals Agency (ECHA) in Helsinki.
In 2010, President Obama signed the Dodd‐Frank Consumer Protection Act into law. Section 1502 of that act addresses the international trade and use of Conflict Minerals. Versa Electronics continues diligence in complying with the requirements of Dodd-Frank. Please contact your Versa representative for a copy of our Conflict Minerals statement.
EPA, FAR, NAFTA, MDH, MPCA, HCHW, CAN TSSA Compliant
Versa Electronics maintains compliance to many other environmental, health, trade and federal acquisition regulatory bodies and standards.