Question

MERMED Inc. is a medical device manufacturer.

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

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

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

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

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

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

3. If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

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

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

QUESTION 4

The operation of a weighing scale (equipments ID 186749) was reviewed by the inspector in the Box Packing section. The weighing scale was in use during the current shift. The operating procedure (SOP18654) for the scale states that it must be calibrated at the beginning and end of each shift. The operating procedure states that that the calibration of the scales is recorded in a log book(Calibration Log for ID 186749 ). The inspector asked to review this log book. The maintenance technician who was interviewed said that the log book was held by the maintenance technician on the night shift and he always kept it in his desk drawer which was locked.

Answer 1