Hello Experts,
I'm currently in the process of authoring clinical evaluation report for class I medical devices for table accessories and attachments (side rails, clamps, head support, upper and lower limb). I'm struggling to find papers supporting the clinical relevance of these devices.
I understand that it is a requirement for a medical device manufacturer to have a clinical evidence in the technical file addressing section 14 of Essential Requirements.
Can someone advise how I can be compliant with regulatory requirements for this kind of device? Am I required to go to an extent of literature search strategy (inclusion & exclusion criteria), critical appraisal, risk benefit etc. for a table accessories and attachments?
PS - I've drafted CER for class IIa and IIb devices which has been accepted by various regulators. I'm finding class I to be a challenging one
Thank you in advance.
I'm currently in the process of authoring clinical evaluation report for class I medical devices for table accessories and attachments (side rails, clamps, head support, upper and lower limb). I'm struggling to find papers supporting the clinical relevance of these devices.
I understand that it is a requirement for a medical device manufacturer to have a clinical evidence in the technical file addressing section 14 of Essential Requirements.
Can someone advise how I can be compliant with regulatory requirements for this kind of device? Am I required to go to an extent of literature search strategy (inclusion & exclusion criteria), critical appraisal, risk benefit etc. for a table accessories and attachments?
PS - I've drafted CER for class IIa and IIb devices which has been accepted by various regulators. I'm finding class I to be a challenging one
Thank you in advance.