Compliance Consultants can consult with you and assist you in creating the necessary controls to meet
the EC mark (Declaration of Conformity) to a harmonized standard to enable medical device sales in the
European Union. The difference that we offer compared to EC mark auditors is we CREATE the
engineering documentation or work with you - to do it. We know what the auditors expect to see and we
work with you to verify your systems are controlled with the appropriate documentation. Not more; not
less.
Compliance Consultants can audit your processes, then develop a gap analysis. We can mentor you through to create the necessary documents to control the processes you must qualify in.
We can review your engineering organization and products. Then we can advise you what is required to meet EC mark ISO 13485.
The CE Marking is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE mark on a product the manufacturer must draw up a Declaration of Conformity (DoC) in which the manufacturer attests conformity with all relevant New Approach Directives (NADs) and takes sole legal responsibility. In some instances an NAD may require a Notified Body to issue a Certificate of Conformity in order to verify performance of the product or constancy of the production process.
Compliance Consultants does what auditors do not and cannot do. We work with you to create and implement a system that suits your medical device process. We do NOT sell you a pile (or files) of paper where you simply substitute your name and save the file as part of your documentation system.
Compliance Consultants can audit your processes, then develop a gap analysis. We can mentor you through to create the necessary documents to control the processes you must qualify in.
- For hardware...we know development engineering, testing, production control, production, assembly techniques, purchasing, inventory and documentation.
- For software, we understand the creation process of design, code, debug. For production, we know what documents are necessary to demonstrate proper testing and repeatability.
- For sterilization, we understand the process from packaging, to placement within containers before exposure, then to QC to measure shelf life.
We can review your engineering organization and products. Then we can advise you what is required to meet EC mark ISO 13485.
The CE Marking is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE mark on a product the manufacturer must draw up a Declaration of Conformity (DoC) in which the manufacturer attests conformity with all relevant New Approach Directives (NADs) and takes sole legal responsibility. In some instances an NAD may require a Notified Body to issue a Certificate of Conformity in order to verify performance of the product or constancy of the production process.
Compliance Consultants does what auditors do not and cannot do. We work with you to create and implement a system that suits your medical device process. We do NOT sell you a pile (or files) of paper where you simply substitute your name and save the file as part of your documentation system.
