Medical Device CE Marking

Medical Device CE Marking

At SGR we have over 15 years’ experience in the medical industry and are able to offer assistance with the creation of technical files, risks assessments in accordance with ISO 14971, meeting the essential requirements of the medical device directive, auditing and product testing.


A CE mark is needed for many medical products in the European Economic Area (EEA), the letters ‘CE’ on a product show that the product complies with European legislation. CE marking was created at the beginning of 1992 to help free the restrictions of the European Marketplace. The CE mark ensures that the product is safe for the market, reassures the buyer of the products safety compliance and could potentially reduce the risk of liability claims. CE marking allows the product to be legally circulated on the European market, we can assist you in the preparation of technical documentation to enable you to achieve CE marking.


CE marking is required in the European Union (EU) and member states and the European Economic Area countries (EEAC).


The countries that require CE marking are:


  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lichtenstein
  • Lithuania
  • Luxemburg
  • Malta
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • The Netherlands
  • United Kingdom


In the future, there is likely to be more countries that require CE marking.


What are the benefits of CE Marking?


The implementation of the CE Mark for your product will enable your company to realise a variety of benefits such as the ability for the product to move freely within European Economic Area (EEA) and the European Free Trade (EFT). CE marking is a legal requirement for many products globally, this makes CE marking essential. The CE mark ensures the product will be compliant within the European Economic Area (EEA), another great benefit would be assurance of safety which could result in the reduced risk of liability.


We will be with you every step of the way and can offer you many other products, services and expert consultation. We are widely recommended by a variety of companies for our outstanding services, work ethic and initiative for excellence.


MEDICAL - ISO 13485

ISO 13485 is the internationally recognised standard for quality management within the medical device sector. It is based on the ISO 9001 process model and its main objective is to enable a harmonised approach in the medical device industry.

HEALTH & SAFETY - ISO 45001

ISO 45001 is the internationally recognised standard for the management of health and safety within your business. By implementing a health and safety management system, your business demonstrates a clear desire to improve the health and safety in your company by setting measureable objectives.

HEALTH & SAFETY - CHAS

CHAS stands for Contractors Health and Assessment Scheme, it is an accredited health and safety scheme for the construction industry. Some buyers require CHAS certification before they allow you to tender. This has been seen in public sectors such as schools, colleges etc.

HEALTH & SAFETY - CONSTRUCTIONLINE

With our guidance your organisation can become a member of Constructionline, Constructionline is the biggest register of contractors in the UK for the construction industry. Constructionline has a database of over 8,000 buyers that are a part of over 2,000 organisations, by becoming a registered member of Constructionline it will increase the brand reputation of your company and is an organised way of instilling verified competence to the buyer.

HEALTH & SAFETY - SAFECONTRACTOR

With our guidance your organisation can become an certified member of Safecontractor, once you have been certified as a member you will be added to the online database that the clients of Safecontractor have access to. You can reduce the risk of accidents on your clients premise’s and ensure your health and safety competence in a cost effective way.

QUALITY - ISO 9001

ISO 9001 is the internationally recognised standard for quality management within your business. It provides a systematic and common sense approach to ensure that the activities within your business are controlled, aiming to consistently achieve customer satisfaction by meeting their requirements and expectations.

QUALITY - Supplier Audit

A supplier audit is the process used to demonstrate your level of control over subcontracted processes. These may be carried out during supplier approval or ongoing surviellance of subcontracted processes. It helps to identify risks and opportunities within the subcontracted activities.

Environment -  ISO 14001

ISO 14001 is the internationally recognised standard for environmental management within your business. It focuses on the environmental aspects of your business and how you interact, influence    and control them. You will set objectives and targets for environmental performance and by implementing a programme improve your performance.

FOOD SAFETY -  ISO 22000

ISO 22000 is the internationally recognized for food safety management within your organisation. It helps to minimize food safety hazards within the food chain.

FOOD SAFETY - HACCP

At SGR we can help you with your HACCP (Hazard Analysis and Critical Control Point), it is a system that introduces better food safety to your organisation’s activities when handling food productsand how food is produced to make sure the food is safe to eat.

SGR

Consulting Services Ltd


Implementation and maintenance of Management Systems that meet the requirements of: ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 and PAS 99.

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