Please contact us today for more information on performing QA and RA due diligence audits for medical device companies.
* Please note that we are not qualified to conduct audits for HIPAA compliance or environmental regulations.
Emergo provides due diligence auditing services to firms considering a merger with, or acquisition of, a medical device company. Most clients ask us to perform these audits as a means of ensuring the target company will be able to maintain quality assurance and regulatory compliance in all markets where the device is sold.
We specialize in helping medical device companies comply with international regulations. As a result, we are extremely familiar with the following medical device regulations and can perform audits to determine the extent of compliance with:
Device clearances/approvals are important, but once these have been achieved, some companies are much better at maintaining regulatory compliance than others. While a company may have ISO 13485 certification now, future compliance is not a given. Compliance with the US Quality System Regulation (QSR) is even more difficult to measure since the FDA does not certify the quality system of medical device companies.
Our firm has extensive experience with US and international regulations, so we can perform an audit on your behalf to determine the target company's level of compliance with the following quality system standards and regulations. As part of that process, we will evaluate the company's Quality Manual and Standard Operating Procedures to ensure that applicable regulatory elements are established, implemented, and followed in markets where products are being sold.
Emergo also commonly performs audits to ascertain the level of compliance with other international requirements. These can include a review and analysis of:
Emergo can fully customize an audit to meet your specific needs. We recognize that such audits are often sensitive to the employees of the company being audited. You can be assured that our auditing team will perform their work discreetly and professionally, focusing only on the task at hand and protecting the integrity of confidential information.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
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* Please note that we are not qualified to conduct audits for HIPAA compliance or environmental regulations.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.