Post-Market Surveillance (PMS) is a common part of Medical Device Regulations across the world. Most major regulations, including the FDA’s 21 CFR § 820[1] and the European Union’s EU MDR 2017/745[2] regulations, have clauses detailing how PMS systems should be handled. Aside from meeting regulatory compliance, having a proper PMS system in place can benefit an organization immensely.

A proper PMS system can allow for the early detection of major issues and adverse events. Trials and tests are done pre-market in order to ensure that the product is safe and ready for the market. That being said, unexpected issues will undoubtedly arise after the product is released. PMS will allow for prompt recognition of these issues which will allow for corrective actions to take place, hopefully before any serious damage can be done. Once corrective actions have been taken further steps, such as preventative actions, can be taken.

Early detection of issues will allow a company to get ahead of the problems thus saving time, money, and potentially lives. EMMA International can assist with setting up a Post-Market Surveillance system along with Corrective and Preventive Action (CAPA) procedures. All these procedures will be set up to be compliant with which regulation applies to the market you are selling in. From developing a quality management system to assisting with regulatory submissions, EMMA can help bring your medical product from concept to commercialization. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (April 2020) PART 822 POSTMARKET SURVEILLANCE retrieved on 10/11/21 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=822&showFR=1

[2] EU Regulation (April 2017) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Retrieved on 10/11/21 from: https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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