Eisner Safety Consultants
Eisner Safety Consultants provides global regulatory, safety, and EMC management services to medical device manufacturers, helping them to bring products to market. They offer expertise in IEC 60601 standards, CE marking, FDA submissions, risk management, and international regulations, supporting clients of all sizes across North America, Europe, and worldwide.
Industries
Nr. of Employees
small (1-50)
Eisner Safety Consultants
Portland, Oregon, United States, North America
Products
IVD EMC standards analysis document
A detailed analysis identifying EMC tests required for in vitro diagnostic (IVD) equipment to meet FDA and EU requirements, based on partial recognition of relevant EMC standards.
IVD EMC standards analysis document
A detailed analysis identifying EMC tests required for in vitro diagnostic (IVD) equipment to meet FDA and EU requirements, based on partial recognition of relevant EMC standards.
Services
Safety and EMC compliance consulting
Consulting to achieve compliance with medical electrical safety and EMC standards, including gap analysis, test planning, failure remediation, and liaison with test laboratories.
Technical documentation and design dossier support
Preparation and assessment of EU MDR technical documentation, MDD technical files, design dossiers, US Design History Files, and Canadian technical documentation.
Regulatory submission support
Preparation and review support for regulatory interactions and submissions including Pre-Sub meetings, 510(k)s, PMA/IDE assistance, and agency response support.
Quality system setup and auditing
Set-up of QMS procedures for regulatory compliance and performance of internal and supplier audits against ISO 13485, ISO 9000, FDA QSRs, MDSAP/CMDR, and CE marking requirements.
Design documentation and design-control support
Support to create user needs, product requirements, risk/hazard analyses, requirements traceability, design reviews, and IFU/operator manual content required by design control processes.
Training and workshops on standards and regulatory topics
Training offerings and interactive workshops focused on identifying applicable standards, standards interpretation, and converting standards into actionable compliance plans.
Safety and EMC compliance consulting
Consulting to achieve compliance with medical electrical safety and EMC standards, including gap analysis, test planning, failure remediation, and liaison with test laboratories.
Technical documentation and design dossier support
Preparation and assessment of EU MDR technical documentation, MDD technical files, design dossiers, US Design History Files, and Canadian technical documentation.
Regulatory submission support
Preparation and review support for regulatory interactions and submissions including Pre-Sub meetings, 510(k)s, PMA/IDE assistance, and agency response support.
Quality system setup and auditing
Set-up of QMS procedures for regulatory compliance and performance of internal and supplier audits against ISO 13485, ISO 9000, FDA QSRs, MDSAP/CMDR, and CE marking requirements.
Design documentation and design-control support
Support to create user needs, product requirements, risk/hazard analyses, requirements traceability, design reviews, and IFU/operator manual content required by design control processes.
Training and workshops on standards and regulatory topics
Training offerings and interactive workshops focused on identifying applicable standards, standards interpretation, and converting standards into actionable compliance plans.
Expertise Areas
- Medical electrical safety and EMC compliance
- Regulatory submission preparation (510(k), PMA, IDE, Pre-Sub)
- Technical documentation for EU MDR, MDD, US DHF, and CMDR
- Quality management systems (ISO 13485, FDA QSR) and auditing
Key Technologies
- IEC 60601 series (medical electrical safety standards)
- EMC testing and mitigation
- ISO 14971 risk management
- IEC 62304 software lifecycle and V&V