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Services | Qualitas Compliance LLC

http://www.qualitascompliancellc.com/services

Whether you are looking for an entire quality system developed to fit your business from scratch, a process within the quality system defined or a single SOP written we have been there done that and can be of assistance. View Details ». Our team of experienced auditors will review your system using the “process approach”, and will represent your company during your initial or continuing assessment audit with your notified body. View Details ». View Details ». View Details ». View Details ». Classes on Qu...

2

Blog | Qualitas Compliance LLC

http://www.qualitascompliancellc.com/blog

February 17, 2014. Qualitas Compliance Check for ISO 14971:2012. Is your quality system risk management file up to date for your next audit assessment of ISO 14971? As of July 2012, EN ISO 14971: 2012 replaced EN ISO 14971:2009. The difference between the two standards is the new Annex Zs. This Annex describes the differences and deviation for the European Directives. The risk management file will be reviewed for the following actions:. Have you as the manufacturer reduced risk as much as possible?

3

Quality System Development | Qualitas Compliance LLC

http://www.qualitascompliancellc.com/services/quality-system-development

Whether you are looking for an entire quality system developed to fit your business from scratch, a process within the quality system defined or a single SOP written we have been there done that and can be of assistance. We will work with you every step off the way. We will even represent your company during your initial Stage 1 and Stage 2 assessment with your organization’s notified body. Fill out my online form. Raleigh, NC 27606.

4

Risk Management | Qualitas Compliance LLC

http://www.qualitascompliancellc.com/services/risk-management

Fill out my online form. Qualitas Compliance, LLC is a women owned business focused on successfully navigating the ever-changing quality and regulatory waters of the medical device industry. Raleigh, NC 27606.

5

Onsite Training | Qualitas Compliance LLC

http://www.qualitascompliancellc.com/services/onsite-training

Fill out my online form. Qualitas Compliance, LLC is a women owned business focused on successfully navigating the ever-changing quality and regulatory waters of the medical device industry. Raleigh, NC 27606.

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