European Union
CE marking is a legal requirement for regulated products, and it is a manufacturer's declaration — not something a consultant can issue for you.
CE marking is a legal obligation, not a certificate
For products in scope of an EU directive or regulation, CE marking is mandatory. The manufacturer signs the Declaration of Conformity and carries the liability. Depending on the product's risk class, a Notified Body may have to be involved.
What we do
We help you identify the applicable directives, assemble the technical file, run the harmonised-standard gap analysis, and prepare you for the Notified Body where one is required.
Management systems
ISO 13485 is effectively expected for medical devices under the MDR. European buyers commonly require ISO 9001 and, increasingly, ISO 14001 and supply-chain audits such as SEDEX.
Will an Indian certificate be accepted here?
Yes, where it is issued by a body accredited under the IAF Multilateral Recognition Arrangement. Signatories accept each other's accredited certificates, so a certificate issued in India is recognised in European Union without re-auditing. We make sure the body you use is in scope before you commit.