Whether it is your first approach to the endless World of Medical Industry, or you need help understanding how to apply a certain standard or simply because you don’t have the resources to do it, ALPA Medical was born with the intent to offer the help you always wanted but hard to find.
ALPA Medical expertise can help you with any type of tasks associated to your product(s) or Quality System, providing you the necessary information following a friendly and pragmatic approach. From the usual questions such as “does this standard apply to us ?” to the more generic “how do I CE mark my product ?” until and not limiting to “I want to be certified under MDSAP, what do I need to do ?” we got everything covered for. No more burden documents, no more non-added value steps and no more infinite loops that takes you to nowhere, and that’s a promise !
ALPA Medical has the necessary skills and technical experience to take your company from A to B in the most efficient way, explaining you the reasons why and tailoring each steps to your needs.
our expertise
-CAN HELP YOU WITH THE FOLLOWING-
CE Marking (Europe)
Full preparation FOR mdr
Registration
aPPLICATION OF ARTICLE 120
MDSAP Certification (Canada)
Full preparation
Registration
MDSAP (Brazil, Canada, USA, Japan, Australia)
Full preparation
Registration
Technical Documentation
Construction
Review
Gap Analysis
Quality System
Gap Analysis
Writing of procedures / forms /Work Instructions
Process Approach simplification
Full set up of Quality Management System
Risk Management
Establishment of a Risk Management File
Review and analysis of the entire RMF
Correlation of RMF with applicable standards
Auditing
Internal Audits (first party)
Supplier Audits (second party)
Certification Body Audits (third party)
Mock Unannounced Audits
Mock MDSAP Audits
Process Audits (targeted process specific)
Overview / Gap Analysis
rEMEDIATION PROJECTS