Nick Woyna

Consulting and Lobbying EU, US, PL
Certification and Standard Compliance
mwoyna

I offer expert guidance to businesses in achieving and comprehending compliance standards in Europe, the United States, and Poland. My focus extends to ensuring both product quality and safety, as well as their alignment with local regulations. Many companies often face unnecessary expenses due to the challenges of distinguishing between standards and directives, leading to confusion in regulatory requirements. 

I am here to provide clarity on CEN and UL standards, optimize products for seamless compliance, and facilitate a smooth certification process. My consultancy goes beyond mere compliance; it involves the adaptation of existing standards to keep pace with evolving technology. Moreover, I engage in a comprehensive lobbying process, striving to establish entirely new standards tailored to the specific requirements of my clients.

My collaborative efforts extend to both corporate clients and startups, offering support in navigating the complex realm of EU and US regulations.

about me

Since 2008, I have been actively participating in the creation of standards and directives. As an expert for the Polish Committee for Standardization (PKN), I collaborate with PKN to develop Polish standards. Additionally, as a member of CEN (European Committee for Standardization) and the convenor of the CEN standardization working group since 2011, I actively modify and create new EU standards. 

Simultaneously, since 2015, I have been actively collaborating with the American Underwriters Laboratories (UL) to harmonize UL and US standards, assisting European manufacturers in meeting standardization requirements in the USA.

I work in partnership with leading accreditation laboratories in Europe (TUV, Afnor, Kiwa) and the USA (UL, Omni) to facilitate manufacturers in navigating the certification process.”

Every certification case is unique. Most often, companies come to us with questions such as:

– Does a particular product need certification, and if so, which one?
– Can we sell our device in a particular market without additional permits?
– The certification process keeps extending. How can we expedite it and effectively complete it?
– We meet the requirements in the EU; is that sufficient to sell in Germany, USA or Canada?
– We haven’t found a suitable standard for our product anywhere. What should we do?
– We need to comply with standard X for market Y. Which laboratory conducts such tests? How can we minimize costs?
– Are you a certifying body?
– How much will I pay for a specific certificate?

In the first stage, our office prepares an opinion for the client. It includes all the necessary information needed to make a decision about further certification processes, including:

– Which standard the device is subject to
– Whether there is an obligation to comply with it
– Where to conduct potential tests (either in-house or contact details of an accredited certifying body)
– Whether and how to reduce certification costs
– Whether there is a possibility to adjust the product to meet an existing standard

The cost of such an opinion usually ranges from 2 to 3 working hours. We always present it to the client for approval before starting work. NOTE: The cost of certification itself is assessed separately by accredited laboratories. It depends on both the product category and its complexity. Laboratories never provide pricing without prior review of detailed documentation; therefore, quick estimates are not possible.

We recognize that the costs associated with the certification process can pose a challenge for many businesses. Therefore, we have developed an ebook: “CE Certification: A Practical Guide for Manufacturers and Sellers”. This comprehensive guide will assist you in understanding how to attain CE certification effectively and efficiently.

Order CE Certification: A Practical Guide for Manufacturers and Seller

The second stage is support in the certification process itself. Based on the prepared opinion, the client can go through all the activities independently. However, it often happens that due to various limitations (language barrier, lack of time, need for cost optimization, etc.), supervision over the certification process is transferred to us. The details of each project are individually agreed upon and vary greatly. Most often, we supervise correspondence and implement client’s actions aimed at standard compliance, but there have also been cases where, for example, our team personally supervised device testing in laboratories in the USA and Canada.

Changing standards or creating entirely new ones

This is a time-consuming and patience-requiring topic. What is worth knowing now is that every standard or directive can be modified. If you have come across provisions that prevent you from introducing a product to the market, it may turn out that the standard is outdated and does not reflect the current state of technology. In such a situation, we prepare an action plan and contact the relevant bodies responsible for publishing standards, and together with the client, we create them anew.

Standard Hourly Rate​

1 Hour €200

Package Rates

10 to 50 Hours
€175 per billable hour

Package Rates

50 and More Hours
€150 per billable hour

* All prices are in euros (€) and are subject to applicable taxes and fees.
Please note that the pricing can be customized further based on specific client needs and agreements.

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