Regulatory Advice
We help you understand and meet the regulatory requirements that apply to your product – whether it's EMC, machine safety, medical technology or environmental directives. With up-to-date knowledge and long experience, we guide you all the way to a safe and certified solution.
Safe guidance through complex regulations.
Regulatory requirements for products
Developing a product is more than technology – it’s also about navigating directives, standards and certification requirements. We have extensive experience in regulatory issues ranging from machine safety and EMC to medical technology and environmental directives. We help you understand what applies, what’s changing – and how to stay one step ahead.
Why work with regulatory requirements?
Taking regulatory requirements into account is not just a matter of complying with laws – it is an investment in the quality, safety and market acceptance of the product. By working structured with requirements early in the development process, you reduce the risk of costly rework and delays later on. You get a safer path to certification, easier launch in new markets and stronger trust with both customers and authorities. In short: getting it right from the start pays off – every time.
Developing a product is more than technology – it is also about navigating correctly among directives, standards and certification requirements. We have extensive experience in regulatory issues in everything from machine safety and EMC to medical technology and environmental directives. We help you understand what applies, what is changing – and how to stay one step ahead.
What can we help you with?
We offer advice and support in all parts of the regulatory process – from early requirements interpretation to documentation and contact with certification bodies. Whether it concerns a new product or an upgrade of an existing one, we are there as a reliable partner throughout the entire journey.
Our strength lies in current and applicable knowledge. We continuously follow the development of new laws, directives and standards, so that you do not have to worry about regulatory changes that may affect your product. In areas such as the Machinery Directive, EMC and Medical Devices Regulation (MDR), we have in-depth expertise and experience in guiding our customers from initial analysis to approved certification.
By working proactively with the New Legislative Framework (NLF), we help you future-proof your product development. This means fewer surprises, lower costs and a faster path to market. With us, you get the right support, at the right time – for products that last, both technically and regulatoryly.
Our team
Our team consists of experienced specialists with deep knowledge of both technology and regulations. We help you interpret directives, structure documentation and take your product all the way to certification.
With practical experience from several industries and close cooperation with the development teams, we ensure that the requirements become a natural part of the development – not an obstacle. With us, you not only get expert support, but a committed partner who ensures that your product reaches the market safely and efficiently.
Examples of relevant directives and regulations
Safety and Electrical Equipment
• LVD – Low Voltage Directive 2014/35/EU
• EMC Directive 2014/30/EU
• RED – Radio Equipment Directive 2014/53/EU
• MD – Machinery Directive 2006/42/EC
Medical Technology
• MDR – Medical Device Regulation 2017/745
Environment and Chemicals
• RoHS 2 – Restriction of Hazardous Substances 2011/65/EU
• WEEE 2 – Waste Electronic Equipment 2012/19/EU
• Ecodesign/ERP – Energy and Resource Requirement 2009/125/EC
• REACH – Chemicals Regulation No 1907/2006
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Curious about our projects?
It's not just about meeting the requirements – but understanding them.
Micael Johansson, Project Manager