EMC Consultancy on ‘Edition 4’
4th edition of medical EMC becomes mandatory
The 4th edition of the medical EM standard IEC 60601-1-2:2014 will become mandatory in the United States and the European Union from December 31st 2018 onwards. This new standard will have a major impact on the medical industry.
- The FDA does not require retesting of legacy products unless changes are made to the product that may affect its compliance.
- In the EU however, all devices including legacy devices sold to the EU, must comply with the new 4th edition standard after this date.
- For other regions it varies with the local regulations of the country.
Get this wrong, and you may no longer be allowed to sell your existing product in the EU.
With requirements becoming up to ten times more stringent, you need to take action to introduce a new way of working for your design teams. Optimization of current processes will simply not suffice.
Your benefit
- Design-in of EMC compliance in the earliest possible phase
- (especially valid with regard to the new EMC standard IEC 60601-1-2:2014)
- Speeding up your time-to-market without compromising EMC compliance
- Lowering cost-of-non-quality on EMC related issues
- Prevent – EMC related – costly and time-consuming field issues
Key area of expertise
Direct contact
Tom Buss
EMC Expert
We deliver
All hands-on, knowledge, skills, state-of-the-art tools etc. for your mechanical and electrical design teams to ‘design-in’ EMC compliance.
- Edition 4 gap analysis
- Advice on the applicable EMC standards (e.g. EMC standard IEC 60601-1-2:2014)
- Composition of EMC specifications
- Electromagnetic risk analysis
- EMC, SI & PI, and wireless coexistence simulations
- Architecture recommendations
- Design reviews
- Pre-compliance measurements
- Wireless performance tests
- Audits, training, toolboxes
- And more
Our approach
Depending on your requirements we can:
- participate in your design teams;
- provide on-demand expert technical support to them;
- provide consultancy, training and more.
Methodologies
Design for EMC approach (including: electromagnetic emission and immunity, signal and power integrity (SI & PI), electromagnetic risk management, exposure of humans to electromagnetic fields (EMF), and the reliable performance of wireless connections).
Let us organize a 15” telco on the edition 4 for you Make me an offer for training my design team
What our partners value
EMC consultancy in the spotlight
How to accelerate your innovation process by pro-actively ‘designing-in’ EMC compliance, preventing costly and time-consuming corrective actions at the very end.
Our challenge was to bring new connected innovations to the market. For us, this means validating electromagnetic compatibility.
A new design approach to secure EMC compliance for complex high-speed electronic systems.
Check out our related services
Creating smart connected products and systems requires capabilities beyond the typical hardware and software design and engineering skills.