Guess where most of the delays occur of the 3 stages?
If you guessed during the construction review stage, you are correct.
Lack of documentation or over documentation – Keep in mind that you are the expert of your product. At the beginning of the construction review, the certification engineer needs to understand your product, its intended use and intended environment, etc. Having a good understanding of your product will enable the certification engineer to accurately and expediently evaluate your product against the requirements.
Therefore, submit your documentation package that is sufficient and organized so that it is easy for the certification engineer to find the information. Create folders such as, mechanical drawing, electrical schematic, critical component, IFU/Label, etc.
One of the first steps during a construction review is, verification of “critical components”.
- Does the component have the appropriate certification mark(s) for the intended market(s)?
- Is the component used within its intended certified ratings or specifications?
Be specific and clear with component information. Some certification bodies will require certification file/ref numbers on critical components.
I can recall spending hours during a construction review emailing and/or calling customers requesting for additional information. Time is wasted when this occurs and it also interrupts your day. The small amount of time you put into organizing your documents and providing sufficient information will benefit both you and the certification engineer.
Note: A certification engineer typically has more than one project and if they are waiting on information from you then your project sits on idle and the certification engineer will work on other projects.
Success Story: During my tenure with a wound care device company, we successfully obtained certification with zero non-compliance in about 2 weeks on an open abdomen wound care device.