Compliance can be daunting, with extensive research needed to identify relevant directives and ongoing work to keep track of updated requirements. We can help you plan for compliance from the earliest stages of the project, or perform gap analysis for your existing products.
BLS is a trusted and experienced provider of electronic compliance services. Working in line with the latest regulations, our compliance consultants ensure products are able to access UK, EU and global markets through accurate and reliable CE marking, global compliance certification, EMC testing and more.
We always approach every project with compliance in mind, so that any compliance requirements are integral to the device. This helps to keep development costs low, and allows for a quicker route to market.
We regularly work with all the common domestic and industrial standards and their related safety requirements, but we also specialise in working with more stringent requirements, such as for medical devices and explosive environments.
Services
Compliance support
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One of the easiest ways to demonstrate electronic compliance with a required standard is with a technical file.
The file describes the whole product or device and the measures taken to ensure it is compliant with the standard in question. It will also include the detailed reports from any testing houses or notified bodies.
The technical file typically needs to be kept for the product lifetime plus five years.
Our compliance experts will work alongside you to create your technical file, ensuring it contains all the relevant information, evidence, and documentation. Our technical file creation services include:
Building technical files for both new and existing devices
Reviewing standards and recording how compliance has been achieved
Reviewing the design to ensure that the technical file is correct and the necessary safety requirements have been considered
Collating all component datasheets where necessary
CE/UKCA safety compliance
It is a legal requirement that products placed on the market in the UK or EU need to be UKCA or CE marked to indicate they are compliant with the required standards.
As well as ensuring new products are fully compliant, we can also take existing products and guide you through the process of testing, documentation and evaluation, so you can determine if any actions are required to achieve CE/UKCA compliance.
Typical standards we work with include:
IEC 60335
IEC 62368
IEC 61000
EN 300 328
EN 301 489
IEC 64000
MIL-STD
Products designed for defence organisations are usually required to meet MIL-STD. Similarly to ATEX/IECEx and medical devices, these standards typically require more attention than those governing domestic devices.
Our consultants are experienced in working with clients to develop devices in line with the standards for a range of specialist applications such as aerospace, vehicles and special environments.
Example standards we work with include:
MIL-STD-810
MIL-STD-461
MIL-STD-1795
MIL-STD-1757
MIL-STD-704
MIL-STD-1275
Medical device standards
Medical devices have to meet rigorous standards to ensure they are safe for use.
Our highly experienced team will guide you through the process of engaging with an external test house to validate that the finished product meets the required standards.
We can also help you develop software compatible with ISO 13485, ensuring you understand the regulatory requirements and testing involved.
When working on a device development, we can support you with:
Component selection and system architecture
Technical file and documentation
Compliant system architecture
Failure mode analysis
Turnkey device development
Type testing guidance
Identification and evaluation of software of unknown provenance (SOUP)
Development methodology in line with ISO 13485 requirements.
ATEX/IECEx
All these devices fall under the IEC 60079 standard, which lays out the requirements for ensuring they are designed safely. Our consultants have a wealth of experience in guiding clients through the development of intrinsically safe devices under these standards.
We can support you with:
Designing Ex-I devices for all zones, temperature groups and gas/dust groups
Designing Ex-d, Ex-e and Ex-p devices
Producing detailed technical files
Preparation for notified body testing and the ongoing process
Electrical
In the UK we work to BS 7671, though we can work to local standards and special areas (e.g. offshore installations for DNV OS-201).We review designs and provide you with third-party assurance that the electrical feed requirements, electrical drawings, single-line diagrams, and calculations are correct.
Calculations per circuit for traceability and upgrades
EMC testing and compliance
EMC testing can be seen as a ‘black art’ but, through careful planning and consideration during the early phases of the design, the risks can be significantly minimised and the number of rounds of testing required can be significantly reduced. In fact, we have a proven track record for ensuring products we have designed pass EMC testing first time.
We take existing devices, determine the relevant testing standards and work with an external testing house to carry out the required tests. We can also work with you to fix any failures or issues from the testing.
We can support you with:
Radio Emissions Directive (RED)
IEC 61000, EN 300 328, EN 301 489, IEC 64000
MIL-STD-461
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