• Product submissions (e.g. FDA 510(k) or CE marking)
• Review of Technical Documentation (e.g. STED or EU MDR)
• Risk management according to ISO 14971
• Software development according to EN 62304 and EN 82304-1
• Artificial Intelligence (AI) and Machine Learning (ML)
• Software as a Medical Device (SaMD) and Software as a Service (SaaS)
• Cloud and mobile devices
• Process optimizations and process interfaces across the Quality Management System (QMS)
• Document control
• Internal and external audits like EU MDR, MDSAP, or FDA inspections (frontroom/backroom)
• Supplier management and supplier audits
• Corrective and Preventive Actions (CAPA)
• Remediation
• Tool Validation
• Complaint Handling and Vigilance
• Field Actions and Recalls
• Non-conformities
• Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC)
• Project support and planning
Company Details
- Employees
- 1
- Address
- Isen, 84424, De
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- (SaaS).
- HQ
- Isen
Bergenthal Consulting Questions
Bergenthal Consulting's website is https://www.bergenthal-consulting.com/
Bergenthal Consulting's LinkedIn profile is https://de.linkedin.com/company/bergenthal-consulting
Bergenthal Consulting has
1 employees.
View email and phone details for 1
employees at Bergenthal Consulting.
Bergenthal Consulting's industry is
Medical Equipment Manufacturing
Bergenthal Consulting's top competitors are
Naturalselection.ai,
Klugdrive Ai,
Neuralrays Ai Europe,
Drive&act,
0xf Research,
Kmflabs,
Smartfly.ai,
Df2 Solutions,
Aivsol,
Patrick Klyeisen Ai & Automation Development.
Bergenthal Consulting's categories are Medical Equipment Manufacturing
