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
2866 NW Fairfax Terrace, Portland, OR 97210
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
Consulting to achieve compliance with medical electrical safety and EMC standards, including gap analysis, test planning, failure remediation, and liaison with test laboratories.
Preparation and assessment of EU MDR technical documentation, MDD technical files, design dossiers, US Design History Files, and Canadian technical documentation.
Preparation and review support for regulatory interactions and submissions including Pre-Sub meetings, 510(k)s, PMA/IDE assistance, and agency response support.
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.
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 offerings and interactive workshops focused on identifying applicable standards, standards interpretation, and converting standards into actionable compliance plans.
Consulting to achieve compliance with medical electrical safety and EMC standards, including gap analysis, test planning, failure remediation, and liaison with test laboratories.
Preparation and assessment of EU MDR technical documentation, MDD technical files, design dossiers, US Design History Files, and Canadian technical documentation.
Preparation and review support for regulatory interactions and submissions including Pre-Sub meetings, 510(k)s, PMA/IDE assistance, and agency response support.
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.
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 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
News & Updates
Published 11 June 2015, discusses how IEC 60601-1 3rd edition is used by regulatory and standards organizations in the USA and Canada.
Published May 2012, discusses the national implementation of IEC 60601-1:2005 into EU, Canada, USA, and Brazil.
Published September 2009, discusses when IEC 60601-1:2005 will be mandatory in US, EU, and Canada.
Published September 2006, discusses the new US standard ANSI/AAMI ES 60601-1:2005.
Published May 2006, covers IEC 60601-1 and its major changes.
Published January 2005, discusses risk management in IEC 60601-1.
Published 11 June 2015, discusses how IEC 60601-1 3rd edition is used by regulatory and standards organizations in the USA and Canada.
Published May 2012, discusses the national implementation of IEC 60601-1:2005 into EU, Canada, USA, and Brazil.
Published September 2009, discusses when IEC 60601-1:2005 will be mandatory in US, EU, and Canada.
Published September 2006, discusses the new US standard ANSI/AAMI ES 60601-1:2005.
Published May 2006, covers IEC 60601-1 and its major changes.
Published January 2005, discusses risk management in IEC 60601-1.