SOP Sales
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
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
Under EU MDR 2017/745:
- Article 7 prohibits misleading marketing and advertising claims
- Marketing must align with intended purpose and conformity assessment
- Claims must be substantiated by clinical evidence
- Distance sales restrictions and authorized representative requirements
- PRRC oversight of marketing claims and customer communications
Special attention required for:
- Clinical evidence substantiation for all performance claims
- IVDR Article 6 restrictions on distance sales for certain device classes
- Language requirements for labeling and instructions for use
- German MPDG requirements for medical device consultants
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
Customer Onboarding Process:
- 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
Claim Substantiation Example:
- 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
Distribution Controls:
- 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