Gaining the right approvals and certificates for products is fundamental both to their success and to ensuring their appropriateness and safety. Organizations need to ensure they have all the required approvals before they launch a product, as delays in obtaining them can be very costly.
We are uniquely placed to provide training on all types of products and quality marks - from CE marking in the EU, to the complex and detailed requirements set out for healthcare products around the world.
Products for use in the global healthcare markets face a range of demanding regulatory approval requirements and standards. We have world-class experts who specialise in training organisations to meet these standards in full.
This includes training for regulatory specialists on the demands of the Medical Device Directive and other countries' regulations; training for ISO 13485 Medical Devices, which relates specifically to Medical Device Regulatory Approval; and assessor training for company internal assessors.
We also provide expert insight into emerging requirements and regulations, and provide services that help manufacturers understand what they need to do to ensure they have regulatory compliant healthcare products throughout the world.
