Kahlity We are a team of dynamic consultants with a proven track record for managing projects and providing consulting services to companies within the medical devices and pharmaceutical industries

Auditing

  Internal Audits  

 

Our consultants conduct internal audits of specific processes, or your full QMS. We follow your internal audit process by using your templates and following your audit programme.

We can also design, implement, maintain and improve your internal audit process.

 

Who would be interested by this service?

All ISO certified companies

Supplier Audits

By conducting supplier audits, we help you to qualify your new suppliers, or evaluate your existing suppliers. 

We follow your supplier handling process by using your templates and following your supplier audit programme.

We can also design, implement, maintain and improve your supplier handling process.

 

Who would be interested by this service?

All ISO certified companies working with suppliers.

 

Gap Assessments

Our consultants conduct gap assessments between your QMS or your technical documentation and applicable requirements. 

We provide you a gap assessment report including a list of potential gaps, and we guide you to define an action plan to close potential gaps.

 

Who would be interested by this service?

All companies willing to be in compliance with new requirements (e.g. from MDD to MDR or from IVDD to IVDR)