Let Verity assist your organization develop the appropriate supporting production and process control documentation to support your QMS, Regulatory Submission, or Agency correspondence
We will work with you to architect a simplified defensible FDA (21 CFR part 820) and ISO 13485 compliant Quality Management System.
Let us help you navigate the complexities of your PRE and POST Regulatory submission efforts to the US, EU, Japan, China, or other countries of the world.
We can help you to satisfy the Quality & Regulatory expectations of Federal Agencies by complying with Regulatory consensus standards like ISO 62304 (RSDLC), ISO 13485 (MDQS), ISO 14971 (MDRM), ISO 62366 (HF), ISO 10993 (Bc), IEC 60601 (E&M Safety) and more…
Take advantage of our deep experience working with Device/IVD Manufactures and Regulatory agencies like the FDA and the EUs Notified Bodies
Auditing & Inspection
Avoid the fear & uncertainty of Quality audits and inspections. Our ISO 13485 lead-auditors and Ex FDA staff, perform Mock inspections of your facility to identify potential 483s or Non-conformity, then prepare you for the audit and inspection.
Human Factor Engineering
Achieve quick and cost-effective approval for your device. We’ll guide you through the complete development and approval process, including an FDA and IEC 62366-compliant Usability Engineering File.
We’ll help you create a usability file without having to learn complicated regulations and conduct complex usability studies.
Improve compliance with less effort and lower costs
As a medical device manufacturer, Regulatory Radar helps you to keep track of the constantly changing regulations and draw the right conclusions from them. Manufacturers are legally obliged to do both.
Post Market Radar
Comfortably fulfill the statutory obligation for post-market surveillance (PMS).
With the Post-Market Radar, medical technology manufacturers can fulfill their PMS obligations quickly and easily. The Post-Market Radar
- supports improved compliance and
- audit reliability with less effort
- and minimizes patients’ risks, by doing away with constant and cumbersome searches of dozens of information sources such as government databases.