QCS can deliver all of your system requirements including design, implementation of a system, document maintenance and update, training, auditing and procedures together with sector/product specific consultancy to meet exact client needs:
Regulatory Advice … We can provide guidance on meeting current and planned regulatory requirements relevant to your product. This can include advice on meeting requirements in markets throughout the world. We can also develop relevant documentation and evidence that is required to support any application you may be making to enter a new market.
CE Certification… We can assist in the development of trials, programmes and activities that are required to meet CE Certification requirements. This includes development of declarations of conformity, dealing with suppliers, product design and materials.
Risk Management… With the new ISO 13485 standard expected to be released during 2016, the draft standard shows an increased importance of risk assessment in developing processes for your organisation. Having the ability to perform risk assessments quickly and routinely will be a major benefit to your business.
Labelling Advice…QCS can provide guidance to ensure your products are labelled correctly for the markets that they are sold in, allowing you to have confidence that you have met the desired labelling requirements for you to finalise your packaging and product design.
Commercialisation of Products… Our consultants can advise early on in the development of new or innovative products on the best route to market. We are also able to highlight areas that may cause difficulties in your commercialisation process and offer solutions to regulatory or market place issues that may be encountered. Areas of expertise include intellectual property advice, market need assessments and benefit analysis. We can also perform competitor analysis and highlight deficiencies in current products.
Signposting for NHS Adoption… Our consultants have considerable experience in negotiating the complicated process to allow your new medical technology to be assessed for suitability by the NHS.
Call Now for your first FREE consultation to discuss how we could help you: 01236 734447