CE Marking & Regulatory

Rapid ce marking for fast progress to clinical trials
CE Marking

Due to our vast range of CE Marked contact lens designs and materials, using our formal processes we can self-certify CE Marking of products based on predicate devices and clinical evaluations.

This allows fast progress to clinical trials that can help determine marketing claims.

Validation of lens designs and processes

The development of a dedicated software suite allows us to validate lens designs, lathe files and processes suitable for CE Mark and FDA approvals.

Quality Control

We have a robust and independent QA sampling and testing environment with a skilled team of technicians.

Our team is well acquainted with the measurement of complex designs and experienced in testing new and innovative materials.

Quality Management has experience of a wide range of industries and is fully conversant with the optical industry regulatory landscape.

CE MARKING & REGULATORY

Industry Standards

We are conversant with all relevant industry standards and regulations involved in the manufacture, validation and supply of contact lenses and related products.

Medical Devices

2007/47/EC (93/42/EEC)
2013/473/EU
920/2013
BS EN 1041: 2008 + A1:2013
BS EN 556-1
BS EN ISO 14971
PD CEN ISO/TR 14969

Quality Systems

BS EN ISO 9004
BS EN ISO 19011
BS EN ISO 9001
BS EN ISO 13485
BS EN ISO 14001

Tolerances

BS EN ISO 18369-2

Shelf Life

BS EN ISO 11987
BS EN ISO 13212

Optical Equipment & Measuring Systems

BS EN ISO 18369-3
BS EN ISO 9342-2
BS EN ISO 10012

Contact lenses & Care Products

BS EN ISO 14534
BS EN ISO 11986
BS EN ISO 11981
ISO 18259
PD ISO/TS 19979:2014
BS EN ISO 18369-4
BS EN ISO 14729
BS EN ISO 11985
BS EN ISO 12864

Sterilisation

BS EN ISO 17665-1
DD CEN ISO 17665-2
PD ISO/TS 17665-3
BS EN ISO 11737-1
BS EN ISO 11737-2
BS EN ISO 10993-1

Labelling & Packaging

BS EN ISO 11978
BS EN ISO 15223-1
BS EN ISO 18369-1 +A1:2009
BS EN ISO 11607-1
BS EN ISO 11607-2

Sampling Systems

BS 6000:1
BS 6000:2
BS 6000:3
BS 6001-0 ISO 2859-10
BS 6001-1 ISO 2859-1
BS 6001-7 ISO 18414

Clean Rooms

BS EN ISO 14698-1
BS EN ISO 14698-2
BS EN ISO 14644-1
BS EN ISO 14644-2
BS EN ISO 11981

Quality Systems

BS EN ISO 9004
BS EN ISO 19011
BS EN ISO 9001
BS EN ISO 13485
BS EN ISO 14001
BS OHSAS 18001

Clinical

BS EN ISO 11980
BS EN ISO 14155

IT Security

BS ISO/ IEC 27001