• Environmental requirements (robustness and safety)
• Applicable Industry Standards
• Toxicity, biocompatibility & chemical requirements
• Sterility requirements
• Industry, corporate or international standards that are required or desired
• Product availability, maintainability
• Versions, models upgrades (to handle added features)
• Material (and biological - for medical products) requirements
• Manufacturing, Service, Warranty and user support system
• Packaging, labeling, shipping
• IP & Security
• Product cost structure requirements
• Import/Export & Government Issues
• MTBF, MTTR and reliability requirements
• Public domain (competition) feedback knowledge
• Regulatory, legal and corporate approvals required

Following are some of the process (or plans, if you like), which may need to be defined by SOPs. Whether a formal SOP is created or another type of management methodology is incorporated into the MRD depends on corporate philosophy. The necessity of each depends on the type of project and product to be developed.

• Product Validation Plans (SOP)
• Contingency and risk plans
• A process to handle ambiguous, incomplete and conflicting requirements
• Project training plans (SOP)
• A procedure for reacting to user, competition, technology and market changes (SOP)
• Project communication and management tools
• Metrics for measuring the end-of-phase outputs for a hold, kill or re-spin decision
• Production, service/support and distribution processes
• Benchmarking against competition and 'best in class' process
• Plans to handle compliance to qualitative, speculative and subjective requirements
• Biocompatibility & biodegradable requirements compliance
• Configuration Control Plans (SOP) [Create a method for handling product changes during the implementation; define how to handle incompleteness of requirements; define both the project and the product change control.]
• "Public concern" reparation plans
• Design Review and Fault/hazard analysis methodologies (SOP)
• Quality Assurance (QA) Plan - based on industry and corporate requirements
• Traceability mechanisms
• Contingency plans for unplanned surprises - e.g. change and risk management procedures for the project are defined (SOP)
• Team incentives
• End-of-life processes (SOP)