ISO 13485 : 2016No.
This certificate shows that the medical device - quality management syetem (EN ISO 13485:2016) of the above company was approved by PCA Certification for the following scope, the validity of the certificate depends on th company's pass the annual survellance audits and company's maintenance the related management system conditions according to international accerditation criteria.
To certify that Quality Management System in accordance with standard's clauses is established and being implemented.
1) had drawn CE Declaration of Conformity in compliance with Annex-VII of
Council Directive 93/42-EEC.
2) has established and maintaining technical documentation of class-1 Surgical & Dental Instruments in compliance with Annex-VII of Council Directive 93/42-EEC.
3) has designated their Authorized Representivate in the European Community in compliance with Article 14(2) of Council Directive 93/42-EEC.
The Surgical Instruments Manufacturers Assosiation of PakistanNo.