Example 1: Automated Processing Line

We provided CE assistance and advice to a UK based company specializing in the design, manufacture and installation of custom automated processing lines. The detailed aspects of these large automated lines were designed and assembled by a sub-contractor in China and installed in Europe. We provided a range of assistance including

• Advice concerning the process and applicable directives

• Initial reviews of design approaches and detailed drawings

• On-site assessment of the machine against identified harmonized standards

• On-site recommendations and assistance resulting in changes to ensure compliance

• Production of all support technical documentation

Example 2: Automated Package Handling Line

We provided CE assistance and advice to a UK based company that had purchased a complete automated package handling system from a manufacturer from Australasia. The system was not CE marked and the manufacturer had no authorized representative within the EU, thus the responsibility for compliance lay with the customer. We provided assistance that enabled them complete the process. The help we provided included the following,

• On-site assessment of the machine against identified harmonized standards which resulted in extensive requirements for corrective actions

• Guidance concerning the options available for remedial action

• Assessment of work carried out by the manufacturers installers

• Recommendations for suitable personnel to complete the task (our associates)

• Production of all support technical documentation

• On-site reviews

• Pragmatic solutions

• All aspects covered

<back

A large proportion of specialist, high technology equipment such as scientific instrumentation is designed and produced by small and medium sized companies. It is not unusual for the detailed regulatory requirements to be forgotten about when the time pressures of new product development start to take their toll.

We have built up long term relationships with manufacturers which allow us to provide simple, pragmatic help with such issues as electrical safety and reduction in EM emissions and susceptibility. We also provide a remedial service for products that are about to launch (or have already escaped!) and still have problems.

On example of this was an "emergency" remedial programme undertaken for a UK-based scientific instrument manufacturer. They had developed a new unit as a replacement for an ageing product. A few weeks before launch is was sent to us for assessment; unfortunately after an initial EMC assessment it was apparent that the EM emissions from the unit were at an unacceptable level. It was agreed that we would carry out modification work to remedy the situation and provide a set of detailed corrective actions to bring the existing production unit into compliance. This work was completed quickly ensuring that the launch date did not need to be changed.

• LVD and EMC assessments

• Pragmatic solutions

• Remedial actions

• Quick response

<back

Example 1: Small electrical equipment

A US manufacturer of electrical equipment used in skin care service sector was looking to export to Europe and required its equipment to be CE marked. It had investigated getting local assistance but this proved both difficult and potentially very expensive. They contacted us and following initial discussions it was agreed that a unit would be set for initial evaluation (free of charge). Following the initial review it was apparent that he unit would not be acceptable in the original form. It was proposed that remedial action be carried out before the detailed assessments, this was agreed in advance.  We subsequently provided the following,

• Rewiring and replacement of key components

• Detailed LVD assessment and EMC testing

• Production of detailed information concerning required changes

• Production of all support technical documentation

The Company has now established a European representative and it starting to promote the units in the UK.

Example 2: Electrically controlled, hydraulically powered platforms 

Working with a UK representative we provided CE assistance and advice to a US based company that manufactures large powered platforms for use in a range of industrial applications such as for accessing chemical tankers during unloading etc. The units are classified as machines and can be operated in potentially explosive atmospheres. We provided a range of assistance including

• Advice concerning the process and applicable directives

• Initial reviews of design approaches and detailed drawings

• On-site assessment of the machine against identified harmonized standards

• On-site recommendations and assistance resulting in changes to ensure compliance

• Production of all support technical documentation

• Remedial actions

• Pragmatic solutions

• Detailed assessments

• Complete solutions

<back

Class 1 devices - CE Marking

Although the requirements are relatively straightforward, CE marking for low risk medical devices can still provide a number of headaches for small businesses, we have helped in a variety of ways including,

• Providing a complete service from initial assessments through to advise on MHRA registration

• General guidance and assistance

• Preparation of templates for assessments of multiple products

• On-site training of staff

Higher Class devices - CE Marking, ISO 13485 etc.

The compliance requirements are more complex for Class 1 devices that are Sterile or have a measuring function and for all higher Class devices, . One requirement is to show that the "manufacturer" has an "appropriate Quality system in place. The normal method of demonstrating that a suitable system is in place is to ensure that it complies with the requirements of ISO 13485. We have provided advice and assistance for Class 1 sterile and an Class 2A devices, these have included the following,

• Advice concerning the process and applicable directives

• Initial reviews of documentation and records

• Detailed help with putting together a quality system that complies with ISO 13485

• Provision of "internal" audits

• Review of all detailed technical documentation or production of such technical documentation

• On-site reviews

• Pragmatic solutions

• Detailed assessments

<back