Compliance Support:

Helping your electronic & embedded products meet regulatory standards

Reassurance in regulated markets

Navigating the complexities of compliance can be overwhelming, and companies don’t always have the resources to feel confident in meeting regulations for electronic products on their own.

We help companies prepare their electronic products for market by designing for compliance. We understand the nuances of industry compliance and how it applies to electronic devices, embedded software, and medical devices.

We can provide compliance support throughout your product development or as a standalone service. And if you require support in a niche sector, we have a network of specialists who can provide additional guidance.

Electronic product certification support

Industry standards and practices are constantly evolving, and meeting these requirements is vital to being able to legally sell your product.

We view electronics and software compliance as an essential element of every electronic and embedded software project. We can manage pre-compliance testing and support you with full compliance testing by working with an accredited test lab.

 

A few of the areas we can help you in include:

  •  Conformité Européenne (CE) marking compliance

  • UK Conformity Assessed (UKCA) compliance consulting

  • Federal Communications Commission (FCC) support for the USA

  • Underwriters Laboratories (UL) and MET mark compliance

  • Radio Equipment Directive (RED) regulations

  • Low Voltage Directive (LVD) compliance support

  • Electromagnetic Compatibility (EMC) compliance standards

  • Medical device (MDR) and In Vitro Diagnostic (IVD) regulations

Medical and Diagnostic Device Compliance Support

Compliance is essential in the MedTech industry, where medical and diagnostic devices must meet strict criteria. In addition to standards such as EMC and RFI, your product may also have to comply with IVD regulatory compliance and medical device regulations. In any case, we can help guide your medical and diagnostic devices towards meeting the required industry standards, so that they go on to receive regulatory approval for your required territories such as Europe and the USA.

Our team regularly works to the following standards:

  • ISO 13485 – the Quality Management System (QMS) for medical device development

  • ISO 14971 – the risk management process used in medical device development

  • IEC 60601 – safety and performance of electrical medical equipment

  • IEC 61010 - safety requirements for electrical equipment for measurement, control & lab use

  • IEC 62304 – medical software development lifecycle

Electronics Compliance Testing

Nicholas Hitchins, Accunea

‘‘Adam, Christa and the team at Ripcord have provided an extremely professional and diligent service in assisting Accunea in the development of our IVD platform. Ripcord led the electronics and embedded software development of our complex medical device development. The project has been challenging and required liaising between multiple parties. The communication and time management has always been excellent, and Ripcord will continue to be a valued supplier to Accunea in the future.’’