Design Reality

Does your product need to be certified?

Certification proves a commitment to quality and safety and affirms that a product has passed specific performance and quality assurance tests, giving sellers and users of products peace of mind. It is therefore a crucial part of the product design process.

Many different types of products require certification before launching to market. This could be to prove safety, compliance with market regulations or simply to show that a product is fit for purpose. It is a necessity in a wide range of sectors, including medical, industrial and consumer.  Even everyday objects will have likely been through rigorous tests before making it into our homes.

Our designers plan product prototypes complete with certification; therefore, we can guide businesses through the process to ensure certification is granted. In fact, we prefer to include this service for our customers - after all, who wants to have gone through the process of designing a new product, see it undergo various tests, be refused certification and ultimately, prevented from going to market.

Whether you are looking to achieve ISO 13485 accreditation for medical device quality in Europe or CE certification for a product design globally, the basic process of certification is the same for all products, regardless of sector. There are four key elements involved for most product certification processes, outlined below*:

  1. Initiation and planning – preparation of documentation, project planning with timings, deciding on resources for the process and the team.
  2. Certification – independent auditors review your documentation and perform controlled tests.
  3. Accreditation – the certifying authority reviews the completed tests and results and validates the process and information before making an accreditation decision.
  4. Continuous monitoring – a process of continuous monitoring is implemented to detect any performance changes.

We have traditionally worked in a number of heavily regulated sectors, such as designing for the PPE and medical industries.  As a result, our team understands the importance of fully preparing for the regulatory tests before a design commences. You can see examples of such work here and here.

Our design team has years of experience supporting clients through a wide range of certification processes. In fact, as part of our long-term commitment to quality and to meet the specific needs of our medical clients, we’ve been awarded certification to ISO 13485 for the internationally recognised standard for quality management. This new accreditation means that we can deliver regulatory compliant development programmes for medical devices to healthcare companies in Europe. For large healthcare and medical device companies, we can minimise the design cycle and cost associated with integrating an external contractor into their own quality management systems. In addition to speeding up the development process, this ensures that quality management is seamless throughout every stage. For medical start-ups, we can provide an outsourced product development with integrated management programme to deliver a design service with all the necessary regulatory filings in Europe.

We have achieved CE certification for many clients, created Class II medical devices and met IP65 ratings.  As part of our Research phase of working with clients, we actively research the latest legislative changes in the market to ensure we are designing a compliant product from the start. 

To find out more about our compliance and product testing services and to speak to someone about compliance for your product, please get in touch.

 *Source: https://www.qtsdatacenters.com/resources/articles/the-four-phases-of-the-certification-and-accreditation-process)

Ellie Yakimov

Marketing Manager

Pagination