What to expect if FDA wants to inspect a Class 1 Medical Device Manufacturer

[Aphel]

Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel

 

[Ronen E]

Re: Class 1 Device Manufacturer - FDA Inspection

Dear all,

Can someone share some information regarding what to expect if FDA wants to inspect a class 1 device manufacturer?
Where should I expect FDA's focus during such an inspection?

Thank you in advance for your support!

BR Aphel

Have a look here