CE Marking
CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, as sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area.
The manufacturer of a product has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up technical files and sign an EC declaration of conformity. These documents must be made available to authorities on request.
Our quality consultant will assist you in obtaining CE Marking by ensuring the following:
- Policies and procedures
- Technical files
- Legal responsibilities
- Guidelines for Regulatory Compliance
- EC declaration of conformity
- Equipment and Software Validations, as applicable
Our quality consultant has 20+ years developing and managing various programs for FDA & MDD Compliance, CLIA, QSIT, CSA along with Commission and Validations for Pharmaceutical & Biotech manufacturing firms as well as FDA Class 2 & 3 Medical Device Manufacturers.
Our consultant is also an ISO 13485 Lead Auditor and experienced with compliance and regulatory requirements for FDA, MDD & CE Marking along with Validation.
He also works at a local A&E Firm that is a world industry leader in design, installation, commission and validation of Pharmaceutical & Biotech plants with major international offices located in San Juan, Puerto Rico, Ireland, Europe, China and Singapore that are key locations for Pharmaceutical & Biotech firms along with Medical Device manufacturing firms.