Howden is your one source for not only all the commercial insurance needs of your firm but also your one source for all the skills and resources needed to assist you with risk management services that Life Sciences companies need in the highly regulated world of medical device manufacturing.

With well-established strategic alliances in the regulatory risk management, product liability prevention, human factors and industrial hygiene, we provide complete turnkey risk management services at whatever levels your needs may be.

We take an interdisciplinary approach to risk management, assessing risk throughout your enterprise & bringing specific services to your operating business units where they can be integrated into your processes. We reject the traditional risk management approach where an insurance company or broker has a “one size fits all” approach to risk management. Our interdisciplinary approach means that we have worked inside medical device companies and for their insurers and know what works, what doesn’t and what practices are critically important to control product liability and operational risks to achieve insurance cost control and product user and patient safety.

Our risk management services are grouped and listed below:

Risk Management Services for the Medical Device and Pharmaceutical Manufactures

• Enterprise Risk Management Studies (Sarbanes-Oxley)
• Mergers and Acquisition Due Diligence Reviews
• Environmental Impairment Liability Assessments
• Product Liability Contract Management Process Analysis
• Controlling Contract liability exposures through Certificate of Insurance Management Procedures
• Document Management and Retention Programs
• (*)“Word Control” and Document Creation for Medical Device Manufacturers
• Product Liability Marketing Reports for Insurance Underwriters

Regulatory Risk Assessment and Management Services

• Safe Product Design Reviews
• Review and Enhancement of Product Risk Assessments and Hazard Control Surveys (FMEA, FTA, HAZOP)
• Manufacturing Process Hazard Analysis
• Human Factors Analysis and Procedure Development
• Warnings, Instructions, Manuals and IFU’s Reviews and Training
• State-of-the-Art Product Assessments for Design Review
• Product Liability Management Evaluations
• Regulatory Risk Assessments (Quality Systems, ISO, GMP)
• FDA Quality System Knowledge Testing, On-site and via Secure Website

     Training:
   - ISO 9001:2000
   - Medical Device Quality System Regulation
   - EU Medical Devices Directives/CE Marking Compliance (Active Implantable, Medical Devices and
     In VitroDiagnostics
   - EU Medical Devices Directives/ Applying Loss Prevention to Risk Management, Legal Requirements and
     Liability Exposure for CE Marking Compliance.
   - Conducting an ISO 9001 Loss Prevention Audits of Product Safety and Product Liability Exposures
   - Conducting an ISO 9001 Loss Prevention Audits of Advertising and Marketing Liability Exposures
   - Conducting an ISO 9001 Loss Prevention Audits of Production/Post Sale Obligations Audits and
     Liability Exposure
   - Conducting an ISO 9001 Loss Prevention Audits of Document Control, Records, Records Management
     and Liability Exposures

• Risk Management GAP Analysis, ISO 9001, FDA Quality Management Systems and Risk Analysis
• Loss Prevention Audits of Risk Analysis/Hazards Analysis Addressing Safety Critical Control Issues

Operational Loss Prevention Services

• Enterprise Business Interruption and Interdependency Studies
• Industrial Hygiene Surveys and Problem Solving
• Occupational Health Management Records Reviews and Program Assessments
• ISO 14001 Environmental, Health and Safety (EHS) GAP Analyses
• OSHA and Regulatory Problem Solving
• Other Safety, Health and Environmental Consulting Services

Publications Available

• ISO 9000 Legal Liability Exposures
• Quality Management Issues for Lawyers
• Applying Risk Analysis to Medical Devices
• FDA, Quality Management Systems: The Risk Management and Legal Implications of Document Control