Critical Regulatory Product Compliance Questions
Type of Product, Application, Market, Compliance, CE Conformity
- What is your typical Product Size/Application?
System size can be anything from small Printed Circuit Boards/Devices/Equipment/ Apparatus/ Subsystems/Subassemblies/Racks to physically large, fixed installations. Systems can be portable, mobile, on the ground, over/under water or in the air.
- What is the intended or possibly abnormal use of our product?
- (risk assessment)
- What is the typical EM-environment, location?
- Which are your target markets for the product?
- a) EU with CE Marking and Declaration of conformity (DoC)
- Do you know which standard have to be used?
- b) Is functional product safety assessment needed? Lab Testing never creates 100% assurance.
- How about your well documented, good engineering practice in design?
- What goes into Technical Product Documentation / user manual?
- c) Market outside the EU?
- d) Is the target OEM Automotive EMC?
- (testing typically according to approved test plan)
- e) Other markets: world commercial, industrial; government / military?
There are international standards defining typical EM-Environments. Do not get lost in the Jungle of exploding numbers in worldwide standards (way over 1000) and e.g. legally required EU DOC for your product. Get external support/guidance.
CE Conformity Assessment, best - optimal Procedures, Technical Documentation
-
Are you aware of differences in CE product conformity assessment?
-
Using harmonized standards (presumption of conformity, “manufacturer self-declaration”) vs. Notified Body product assessment (confirming essential requirements of directive, the highest confidence level).
- Do you know how to smartly integrate regulatory product compliance into early R&D?
- What is better for you? Testing performed internally (in-house) or externally?
- Are you aware of timing, cost, availability, legal risks and measurement uncertainty in testing?
- Do you know the conformity assessment modules for the EU directives, correct choice of product applicable standards / interpretation, test procedures, measurement uncertainty, product performance with pass or fail criteria?
- Do you understand what is needed in technical product documentation?
- How to read an ISO/EN 17025 test report from a non/accredited lab?
- How can external eyewitness testing help you?
If you are not really sure do not hesitate and get professional help swiftly: Phone: +41 56 633 73 81