Dear,
Hope I find someone who can help with the following.
We are looking for a Written quality policy with clear Scope of the QMS as per ISO 13485, Clause 4.2, Requirements for regulatory purposes for Medical Devices Authorized Representatives..
The policy should contain the following policies:
1- Company Policy
2- Distribution ( Defined procedures and processes Forms)
3- Importation ( Defined procedures and processes Forms)
4- Complaint Handling ( Defined procedures and processes Forms)
5- Adverse Events ( Defined procedures and processes Forms)
6- Recalls ( Defined procedures and processes Forms)
7- Alerts and modifications ( Defined procedures and processes Forms
Hope I find someone who can help with the following.
We are looking for a Written quality policy with clear Scope of the QMS as per ISO 13485, Clause 4.2, Requirements for regulatory purposes for Medical Devices Authorized Representatives..
The policy should contain the following policies:
1- Company Policy
2- Distribution ( Defined procedures and processes Forms)
3- Importation ( Defined procedures and processes Forms)
4- Complaint Handling ( Defined procedures and processes Forms)
5- Adverse Events ( Defined procedures and processes Forms)
6- Recalls ( Defined procedures and processes Forms)
7- Alerts and modifications ( Defined procedures and processes Forms