Company Information: MERMED Inc. is a medical device manufacturer. The company’s
ID: 327767 • Letter: C
Question
Company Information:
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 2
The software used in the automated processes on line XYZ is not validated
Explanation / Answer
Answer: 2
Non conformance Issue observed in the plant :
It is observed during the audit at the MERMED Inc.(medical device manufacture) that the software used in the automated processes in the XYZ line are not validated and the records for the validation are not available at the plant with the manufacturing team. It is a non conformance at the plant as per the requirements of ISO13485 : 2016 AND 21 CFR 820.
As per the requirement of this standard, the plant software used in the automated processes needs to be validated properly as per the validation process and the records of validation should be maintain at the organization level and upon request from auditor, the auditee should be able to show the records of software validation to the auditor.
It is another non compliance that the non validated software process should not be used in the production process, as it may create non-conformance product in the organization.
The above stated are the non conformances against the requirements of ISO13485 : 2016 AND 21 CFR 820.
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