NEW
Font size
WorksheetsQA requirements
Total questions: 14
Worksheet time: 7mins
Products must be stored within which kind of environment to prevent product tampering or contamination?
a secure, clean, pest free environment
a clean and wide environment
a secure environment
a pest free and clean environment
What elements are included in product traceability?
the dates of product purchases or consignment
customer name, address and at least one contact detail
the quantity, the model number, the lot and / or serial numbers and UPNs
all the above
Channel Partner is required to submit timely implant registration forms to Boston Scientific for all active implantable medical devices and their accessories, when applicable in the territory.
True
False
Channel Partners shall ensure that installation, servicing, preventive maintenance, electrical safety testing are performed by qualified personnel as per the applicable IFU/DFUs or as per applicable regulatory requirements.
True
False
Within how many days from awareness day, a complaint notification should be reported to BSC?
2 days
5 days
1 day
the soonest possible but not later than 3 days
What would you do if you have Bio/hazardous or Hazardous Product Returns
no special action is required
products must be returned in biohazard controlled packaging and under safe handling controls
ask courier for instructions
no need to return
Channel Partner shall not inform Boston Scientific within a reasonable period of time of any changes to the vigilance or any other medical device adverse event reporting requirements within the territory
True
False
When you are notified for a Field Action what is the first action you shall do?
contact your customers
return the acknowledgment/verification form
Read carefully the instructions given by BSC and act accordingly
return impacted devices
Not For Human Use Units (non-sterile except for animal studies, not for human use) shall be used by Channel Partner for demonstration purposes only and shall never be used in a live clinical environment
True
False
Channel Partner is responsible for ensuring that product labeling meets applicable regulations, with the exception of countries in the EU where BSC has full responsibility for all labeling
True
False
Channel Partner is responsible for maintaining Quality training records if not trained by BSC personnel. What those records shall include?
the name(s) of the trainer(s)
the date and content of the training
full names of attendees
all the above
All records which demonstrate conformance to the specified requirements and effective operation of this Quality Annex must be retained by the Channel Partner, with copies provided to Boston Scientific upon request
True
False
Channel Partner that distributes Boston Scientific products through Sub-Channel Partners, remains responsible for ensuring compliance with the Quality requirements in this Annex as well as any complementary/supplementary ones are complied with until the product reaches the end customer.
True
False
BSC does not have the right to perform on-site Quality assessments of the Channel Partner facilities and processes
True
False
