Sometimes the problem is just too big to handle with internal resources or expertise. Other times you just need an independent point of view. Either way, we are here to help you achieve success.
#consulting #medicaldevices #success
Another CAPA on CAPA? We can promise you are not alone. Want to fix it right once and for all? The experts at MEDIcept can help with that. Call us at (508) 231-8842 or email sreilly@medicept.com to set up an initial consult!
#medicaldevices #CAPA #consulting #iso13485 #fda
Are you a start-up?
Starting a new company in the highly-regulated medical industry is no easy feat. We can help you at every step of the journey – from product innovation and regulatory strategy, to design controls and risk management, through clinical trials, regulatory submissions, and quality management systems.
#regulatory #medicaldevices #clinicalresearch #compliance #qualitymanagementsystem #startupstrategies
MEDIcept Inc. continues to grow so we can fully meet your consulting needs. Many clients know us for our regulatory or quality expertise. Did you also know we offer full clinical research services? Or engineering support? Until our website catches up with our growth, go to our LinkedIn page for an overview of who we are and what we do!
https://lnkd.in/e9edwCs
As first reported in 2018, the FDA intends to harmonize and modernize the Quality System regulation for medical devices by more closely aligning with ISO 13485:2016. Despite delays, including those caused by COVID related factors, modernization plans continue.
https://www.linkedin.com/feed/update/urn:li:activity:6696787401316065281
#FDA #medicaldevices #harmonization #iso13485 #QSReg #QSR
The latest article in our multi-part risk management series is now available! https://tinyurl.com/y6qss9rk
In our last article, Transferring Risks from Fault Trees to FMEAs, we described an approach for transferring risk information from a completed FTA to an FMEA so that you will be able to take advantage of the strengths of both. Part 4 of this series, Key Terms, will clarify some terminology before we dive into the best practices for conducting a risk assessment.
Comment below or reach out to us with any and all questions.
#riskmanagement #compliance #medicaldeviceconsulting #riskassessment #medicaldevice #iso14971 #medicept
MEDIcept is currently looking for a Senior Regulatory Consultant. Job posting can be found at https://lnkd.in/evwFuME.
Brexit and the changes to medical device regulations coming in 2021. Are you ready???
Check out our latest blog to find out. https://lnkd.in/eAkzmmn
#brexitready #brexit #medicaldevice #compliance
Part 6 in our Risk Management Series of articles is here!
In our last article, Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and distinguishing between harms that occur as a direct result of the hazard/hazardous situation and harms that will only occur as the result of a potential series of subsequent events. This article addresses the other major element of risk, the Probability of Occurrence of Harm.
https://lnkd.in/eTtUvjc
#riskmanagement #compliance #medicaldeviceconsulting #riskassessment #medicaldevice #iso14971 #medicept
Ready for an exciting career with an incredible team? If yes, then we are looking for you! For more information and to apply, go to https://lnkd.in/eYkSV4q.
(Note: The Consultant in Training position is not yet posted on our website. Use this link for more information https://lnkd.in/ewstvyF. Please note this is not an internship. The ideal candidate has 2+ years of experience in the medical device industry.)
#jobs #medicaldevice #hiring #consultingcareers #regulatory #quality #clinical
Want to learn more about the FDA Safer Technologies Program? FDA is hosting a webinar today on STeP for Medical Devices. Registration is not required.
Date: Monday, February 1, 2021
Time: 12:00 – 1:30 p.m. EST
#FDA #guidance #regulatorystrategy #regulatoryaffairs
FDA.GOV
Webinar - Safer Technologies Program: Final Guidance
FDA has placed all alcohol-based hand sanitizers from Mexico on an import alert to help stop products that be in violation from entering the U.S. until the agency is able to review the products’ safety. The agency has seen a significant number of hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination or 1-propanol.
For more information, please read the FDA alert.
FDA.GOV
Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
Now it's easier to contact MEDIcept Inc.
MEDIcept Inc. is excited to announce the latest addition to our team! Cheron Legault joins us as the first member of our 2021 consultant training class and will be actively supporting our client base in the area of Quality services.
Please join us in welcoming Cheron to MEDIcept!
#welcometotheteam #consulting #fda #ISO #quality
The 2021 announcements just keep coming! We'd love for you to check out our brand new website at www.medicept.com.
#medicept #website #consulting
