FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.
FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works. Each year, FDA clears thousands of medical devices via the 510(k) process. An overwhelming majority of those devices (80%+) go through the Traditional 510(k) process. Less than 2% go through the alluring Abbreviated 510(k) process. Why? Well, frankly […]
Read More
How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors
How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors For a new auditor, the opening meeting is critical. How you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear unsure and unorganized, your audit will not […]
Read More
Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor
Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor You├óΓé¼Γäóve heard it many times before: ├óΓé¼┼ôGreat├é┬á(insert any profession here)├é┬áare made, not born.├óΓé¼┬¥ The saying is especially applicable to auditors.├é┬áTruly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to […]
Read More
How to Prepare for and Conduct an ISO 13485 Internal QMS Audit
How to Prepare for and Conduct an ISO 13485 Internal QMS Audit Covered in this guide: ├é┬á Real Purpose of the Medical Device QMS AuditBasic Types of ISO 13485 Audits├é┬áDeveloping Your Overall ISO 13485 Audit SchedulePreparing for Your ISO 13485:2016 QMS AuditConducting a QMS Documentation ReviewRole of the ISO 13485 Lead AuditorCreating the QMS Audit […]
Read More
6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months
The next 12 months are sure to be a wild ride for medical device RA/QA professionals. ThereΓÇÖs a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase ΓÇô you may have seen it happening already. HereΓÇÖs what we are hearing from our clients […]
Read More
The US FDA is Shifting Toward ISO 13485. But How Much and How Soon?
Earlier this month, the US FDA officially announced their intention to shift toward international harmonization of the US Quality System Regulation (QSR). The medical device industry is likely to give a collective thumbs-up to the proposal, although its impact is unlikely to be felt anytime soon. Known more formally as 21 CFR Part 820, the […]
Read More
