Product Development CE Marking
By affixing the CE Marking, the manufacturer, or its representative, or the importer assures that the item meets all the essential requirements of all applicable EU directives. CE Marking includes Construction Products, Containers, Cranes, Electrical Products and Components, Electromagnetic Compatibility (EMC), Lifts, Marine Equipment, Materials, Mechanical Products, Process Machines, Pressure equipment, Personal Protective Equipment (PPE), Telecom, Toys and Wood. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, etc…can further reduce timescales and costs.
KEY BENEFITS
• Opens acceptance worlwide of your products.
• It is mandatory to understand your obligations and demonstrate compliance
• Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R,ROHS etc…can further reduce timescales and costs
OUR APPROACH
One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage.
Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, what are your quality expectations?
The responses help us to identify the regulatory barriers, the directives, the standards, your conformity assessment route option, etc…And to develop a rationalised compliance plan for your product range with your target markets within, as well as outside, the EU.
SCOPE OF DIRECTIVES
• Medical Device Directive – 93/42/EEC
• Low Voltage Device Directive – 2006/95/EC
• Machinery Directive – 2006/42/EC
• Construction Product Regulation – (EU) 305/2011
• Electromagnetic Compatibility Directive – 2004/108/EC
• Pressure Equipment Directive – 97/23/EC
• Simple pressure vessels Directive – 87/404/EEC
• Personal Protective Equipment Directive – 89/686/EEC
Certifications
- ISO 9001:2015
- ISO 27001
- HACCP
- ISO 22716:2007
- AS 9100D
- ISO/IEC 20000-1:2011
- GDPR
- NCEMA 7000:2015
- Product Certification
- ISO 14001:2015
- CE Marking
- ISO 18788 Certification
- Green and Clean Hospital
- ISO 22301 (Business Continuity)
- ISO 30301 (Records Mgmt)
- ISO 10004:2012 (Customer)
- ISO 26000 (Social Responsibility)
- ISO 41001:2018
- OHSAS 18001:2007
- ISO 22000:2018
- Human Health Care
- GMP Certification
- Inspection and Testing
- ISO/TS 29001:2010 (QMS)
- ISO 10002:2014 (Quality Mgmt)
- ISO 13485:2016 (Medical Devices)
- ISO 55001:2014 (Asset Mgmt)
- ISO 22000:2018 (Food Safety)
- ISO 45001:2018
- CEN/TS 16555-1:2013
- ISO 50001 – Energy
- ISO 20121 (Event Mgmt)
- ISO 31000:2018 (Risk Mgmt)
- ISO 39001:2012 (Road Safety)
- ISO 21001:2018 (Educational)