MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is aglobal leader in developing, manufacturing, selling and servicingdiagnostic imaging and therapeutic medical devices used to diagnoseand treat cardiovascular and other diseases. MERMED earned $300million of revenue in 2015, while employing more than 10,000 peopleworldwide. One of it’s manufacturing plants is located in Dingle,Co. Kerry, Ireland. Tom Jones is the plant manager at the Dinglefacility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000employees. It manufactures a variety of of medical devices(including Class III devices). A number of it's products are soldin the US and European markets. The facility has a QualityManagement System in place. Their Quality Management System is incompliance with ISO 13485:2016 and 21 CFR 820. Their facility isfrequently audited by Notified Bodies and the FDA.

The site was recently audited by corporate. The corporateauditing team were checking the site's compliance with ISO13485:2016 and 21 CFR 820. The auditors found a number of potentialnon-conformances to  ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5incidents/questions):

1.   Review each of these potentialnon-conformances (5 incidents in total)

2. Determine if they are non-conformancesagainst the requirements of the ISO13485:2016AND 21 CFR 820.

3. If they are non-compliances, write down thespecific clause numbers in ISO13485:2016 AND specific section number of21 CFR 820 which is applicable (write down themain clause/section in each regulation that thenon-compliance is against).

Note:  ISO 13485:2016 and 21 CFR 820 are availablein the \"Additional Resources\" section, under the section heading\"Quality Systems Regulations (EU and US)\" (contained within SectionA Medical Device Regulatory Affairs).

4. Briefly EXPLAIN your decision in 100-170words.

QUESTION 4

The operation of a weighing scale (equipments ID 186749) wasreviewed by the inspector in the Box Packing section. The weighingscale was in use during the current shift. The operating procedure(SOP18654) for the scale states that it must be calibrated at thebeginning and end of each shift. The operating procedure statesthat that the calibration of the scales is recorded in a logbook(Calibration Log for ID 186749 ). The inspector asked to reviewthis log book. The maintenance technician who was interviewed saidthat the log book was held by the maintenance technician on thenight shift and he always kept it in his desk drawer which waslocked.