Establish Quality Management System
SOP Sales
Market medical devices through controlled processes ensuring validated claims and compliant distribution channels.
Summary
Your Sales SOP establishes controlled processes for marketing, selling, and distributing medical devices while ensuring all promotional claims are validated, regulatory requirements are met, and only certified products reach customers through compliant distribution channels.Why is SOP Sales important?
Sales controls exist because regulators need assurance that medical devices are marketed truthfully and distributed only to appropriate users. Misleading claims can lead to improper device use, patient harm, and regulatory enforcement actions. The SOP protects patients by ensuring marketing accuracy while protecting your company from regulatory violations and liability. Your sales process also demonstrates that your organization maintains traceability from development through distribution, which is essential for post-market surveillance and field corrective actions. It ensures that only properly certified and released products reach the market, and that customer feedback flows back into your quality system for continuous improvement.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Customer requirements must be reviewed and approved under Section 820.30(c)
- Marketing claims must be substantiated and accurate
- Distribution controls required under Section 820.160
- Promotional labeling regulated under 21 CFR Part 801
- Medical Device Reporting (MDR) requirements for customer feedback
Special attention required for:
- FDA promotional guidance compliance and off-label promotion restrictions
- 510(k) predicate device claims substantiation
- Distributor agreements and complaint handling procedures
- Social media and digital marketing regulatory requirements
Guide
Your Sales SOP establishes controlled marketing and distribution processes that protect both patients and your company. Focus on creating systems that ensure accuracy, traceability, and regulatory compliance throughout the customer journey.Marketing Material Development and Control
Implement a systematic review process for all marketing materials before release. Establish clear criteria for what constitutes a performance or safety claim requiring validation versus general descriptive content. Create approval workflows that involve quality team review for technical accuracy and regulatory compliance. Maintain version control for all marketing materials with clear approval records. Establish procedures for updating materials when product changes occur through your change management process. Include review timelines and responsible parties to ensure materials remain current and accurate.Claim Substantiation and Validation
Develop processes for substantiating all claims with appropriate evidence from your technical documentation, clinical evaluations, or performance studies. Avoid making claims that exceed your intended use or go beyond validated performance characteristics. Create claim libraries that link marketing statements to supporting evidence in your technical files. This provides auditors with clear traceability and helps ensure consistency across all marketing channels. Include processes for reviewing claims when supporting evidence changes.Customer Contract Management
Establish systematic processes for evaluating customer requirements and ensuring your organization can meet contractual obligations. Include feasibility assessments covering product availability, service capabilities, regulatory compliance, and post-sales support requirements. Implement contract review procedures that verify customer understanding of device intended use, user requirements, and any usage restrictions. Document customer communications to support post-market surveillance and complaint management processes.Distribution Controls and Traceability
Create systems for tracking device distribution from release through customer delivery. Implement procedures that ensure only properly released products are distributed and that distribution records support post-market surveillance and field corrective action requirements. Establish customer onboarding processes that verify appropriate user qualifications where required by regulation. Include procedures for handling specialized distribution requirements such as prescription-only or professional-use-only devices.Integration with Quality System
Connect sales processes to post-market surveillance through systematic customer feedback collection. Establish procedures for identifying and escalating quality issues discovered through sales interactions. Include customer complaint handling procedures that feed into your CAPA system. Integrate sales data with management review reporting to track customer satisfaction, complaint trends, and market performance indicators.Example
Scenario
MedTech Solutions launches their diabetes monitoring app in European markets. They need to ensure all marketing claims are substantiated, distribution complies with MDR requirements, and customer feedback flows into their quality system for continuous monitoring and improvement.Sales Process Implementation
Marketing Material Development:- Technical Claims Review: Quality team validates all app performance claims against clinical evaluation data
- Intended Use Alignment: Marketing materials clearly state device is for diabetes self-monitoring, not diagnosis
- Evidence Mapping: Each performance claim linked to specific validation study results
- Regulatory Review: PRRC reviews materials for MDR Article 7 compliance
- Approval Workflow: Marketing manager and quality representative approve materials before release
- Requirement Assessment: Evaluate customer technical requirements and intended use alignment
- Regulatory Verification: Confirm customer location permits device marketing under current CE marking
- Contract Development: Standard terms include intended use restrictions and complaint reporting procedures
- Distribution Authorization: Verify device version matches approved technical documentation
- Post-Sales Support: Establish customer service contact for technical support and complaint handling
- Marketing Claim: “Provides glucose trend analysis with 95% accuracy”
- Supporting Evidence: Clinical validation study report demonstrating 95.2% correlation with reference method
- Documentation Link: Technical file Section 6.3, Clinical Evaluation Report pages 45-52
- Review Record: Quality team approval dated March 15, 2024, approved by Quality Manager
- Customer receives device download link only after contract execution
- Distribution records maintained linking customer to specific software version
- Automated system tracks downloads and installation confirmations
- Customer feedback portal integrated with complaint management system
- Quarterly customer satisfaction surveys feed into management review process
Q&A
What types of marketing claims require validation?
What types of marketing claims require validation?
Any claims related to device performance, safety, accuracy, clinical benefits, or comparative effectiveness require validation with supporting evidence from your technical documentation. General descriptive statements about features or user interface elements typically don’t require formal validation, but should still be accurate and reviewed for regulatory compliance.
How do I ensure marketing materials stay current with product changes?
How do I ensure marketing materials stay current with product changes?
Integrate marketing material review into your change management process. When product modifications occur, include assessment of marketing material impacts in your change control procedures. Maintain a claims database that links marketing statements to supporting evidence, making it easier to identify materials requiring updates.
What are the requirements for customer contracts and agreements?
What are the requirements for customer contracts and agreements?
Customer contracts should include clear statements of intended use, user requirements, any usage restrictions, and complaint reporting procedures. Review customer requirements for feasibility and regulatory compliance before contract execution. Maintain contract records to support post-market surveillance and distribution tracking requirements.
How should customer feedback be integrated into the quality system?
How should customer feedback be integrated into the quality system?
Establish systematic processes for collecting, categorizing, and escalating customer feedback through your complaint management system. Train sales team members to identify quality-related issues and route them appropriately. Include customer satisfaction metrics in management review reporting and trend analysis.
What special requirements apply to international sales?
What special requirements apply to international sales?
Verify regulatory approvals and marketing authorizations for each target market before initiating sales. Consider language requirements for labeling and instructions for use. Some markets have specific requirements like the German MPDG medical device consultant requirements or IVDR restrictions on distance sales for certain device classes.
How do I handle requests for information not covered in approved marketing materials?
How do I handle requests for information not covered in approved marketing materials?
Evaluate whether the requested information constitutes new performance or safety claims requiring formal validation. If the information is substantially similar to approved content, it may be provided. If it represents new claims or goes beyond validated performance characteristics, it must go through your claim validation and approval process before sharing.