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Makromed Inc.
88 Stiles Rd.
Salem, NH 03079 USA
Tel: 603/890-3311
Fax: 603/890-3322
Web: http://www.makromed.com
E-mail: info@makromed.com
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Software, software, and more software...
At Makromed we address all your software needs...for quality, compliance and regulatory purposes:
SOFTWARE SOLUTIONS Our InfoSuite products for quality and regulatory compliance include:
InfoMed – Complaint handling and adverse events reporting
InfoCAPA – Nonconformance and CAPA management
InfoAudit – Internal and vendor audits management
InfoTrain – Employee training management and self-instruction training
modules
InfoSQA – Software development and validation management
Fully integrated, validated, and Part 11 compliant.
SOFTWARE 510(k)s Our software regulatory specialists help you plan, prepare and submit 510(k)s on your software-based medical devices. We now what software-specific information the FDA looks for, and how they want these 510(k)s structured.
SOFTWARE AUDITS Our software QA specialists audit your software development practices. We give you an objective assessment of how well your practices map to the design control requirements. We have the expertise to perform technical evaluation of your software deliverables, such as the quality plan, risk analysis, software requirements, and validation results.
SOFTWARE PART 11 COMPLIANCE We check the overall health of your Part 11 compliance status. We help you establish your Part 11 policies and procedures, identify Part 11-specific gaps in your systems and make recommendations for correction.
SOFTWARE RISK ANALYSIS Our software QA team has the expertise in all aspects of analyzing and managing software risks. We have in- depth working knowledge of ISO 14971 and risk analysis techniques like FTA and FMECA.
SOFTWARE VALIDATION We provide a comprehensive portfolio of software validation services. This includes writing the validation plan and test scripts and tracing them to specific requirements, conducting the tests, preparing the test report, and managing the deviations and regression testing of subsequent changes.
SOFTWARE QA TRAINING We provide hands-on training in all areas of SDLC – conducting risk analysis, writing requirements, preparing validation plans, assessing Part 11 compliance, and auditing software development.
Categories this company is listed under in the North American Suppliers Directory:
- Manufacturing Equipment and Software: Software: Design software (172 companies)
- Manufacturing Equipment and Software: Software: Manufacturing software (247 companies)
- Manufacturing Equipment and Software: Software: Regulatory software (135 companies)
