Elexes helps medical device companies review, standardize, and control sales decks, distributor materials, FAQs, and field-facing content before use with customers, distributors, or healthcare professionals.
Sales materials are among the most frequently used assets in the field.
Yet many medical device companies deploy presentations, brochures, distributor content, and sales tools without a structured compliance review process.
Common Challenges
Many organizations encounter issues such as:
⦿ Materials made by the distributor that are never formally reviewed
⦿ Old sales deck used even after product update
⦿ Lack of proper approval process
⦿ Claims made that contradict approved labeling
⦿ Versions existing all over the organization in different geographies and departments
The Problem
Many companies lack a structured system for reviewing, approving, version-controlling, and standardizing sales materials before field use.
This leads to non-compliant materials being distributed into the field and potentially leading to claims-related issues.
This service is designed for:
⦿ Companies preparing sales materials before product launch
⦿ Organizations handling international sales enablement content
⦿ Organizations using distributors or independent marketers
⦿ Organizations ramping up commercialization efforts
⦿ Companies growing their sales teams
⦿ Companies dealing with issues relating to distributor control
⦿ Companies auditing promotional materials
⦿ Companies facing promotional material compliance concerns
This service is not:
⦿ A marketing content creation or copywriting service
⦿ A substitute for regulatory submissions or approvals
⦿ A labeling-only review service
⦿ A one-time document review without process implementation
⦿ A review of non-claim-based internal communications
⦿ Limited to claim validation alone
Sales material control and compliance, including consistency of message is our primary focus.
Medical device sales teams need materials that are accurate, approved, and consistent.
Elexes assists organizations in establishing practical controls around sales materials before they reach customers, healthcare professionals, distributors, or business partners.
Outcome
Consistent and controlled sales materials across:
⦿ Commercial teams
⦿ Regional organizations
⦿ Distributors and channel partners
⦿ Marketing departments
⦿ Product management functions
Helps reduce avoidable compliance risk across commercialization activities.
We review:
⦿ Sales presentations
⦿ One-pagers/Sales FAQs
⦿ Product summaries
⦿ Distributor-created content
⦿ Sales training materials
We also evaluate how these materials are deployed across different teams, markets, and distribution channels.
We identify:
⦿ Unsupported claims
⦿ Promotional risks
⦿ Labeling inconsistencies
⦿ Version control weaknesses
⦿ Missing approvals
⦿ Distributor content risks
We assist in setting up the proper:
⦿ Material review workflows
⦿ Approval requirements
⦿ Documentation controls
⦿ Version management practices
⦿ Distributor oversight processes
Our goal is to establish compliance on a long-term basis.
Our team:
⦿ Annotates materials
⦿ Recommends corrections
⦿ Aligns claims with approved documentation
⦿ Provides claims substantiation guidance
⦿ Creates approved messaging frameworks
Before deployment, we:
⦿ Review updated content
⦿ Confirm consistency
⦿ Verify claim alignment
⦿ Validate final materials
We support organizations responding to:
⦿ Internal audits
⦿ Quality audits
⦿ Distributor audits
⦿ Regulatory inspections involving promotional materials
⦿ Sales Material Compliance Review Report: Detailed findings and recommendations.
⦿ Annotated Sales Materials: Review of sales material with comments and recommended changes.
⦿ Claims-to-Labeling Alignment Matrix: A comparative table comparing sales claims to approved labeling and documentation.
⦿ Distributor Material Control Framework: Proposes a mechanism covering the examination, authorization, and management of distributor-generated content.
⦿ Approved Messaging Guidelines:Recommended language and messaging parameters for field-facing communications.
⦿ Field Material Review Checklist: Repeatable checklist to be used for evaluating future promotional materials.
Sales materials are often reviewed during audits and inspections.
Without proper control:
⦿ Non-compliance issues resulting in regulatory concern
⦿ Misstatements that can result in audit observations
⦿ Distribution errors that could lead to uncontrolled communication
⦿ Misleading marketing that could hurt the reputation
⦿ Compliance gaps can affect market access activities
Sales materials represent frontline regulatory exposure.
Every field-facing claim should be accurate, controlled, and supported.
Organizations choose Elexes because of our ability to bridge regulatory, marketing, and sales requirements.
⦿ FDA promotional and claims expectations
⦿ EU MDR claims and labeling alignment
⦿ TGA and Health Canada promotional material requirements
⦿ Global expectations for documentation control
⦿ Software as a Medical Device (SaMD)
⦿ Hardware Medical Devices
⦿ Combination Products
⦿ Senior regulatory experts involved
⦿ Claims and labeling consistency expertise
⦿ Distributor material risk management experience
⦿ Cross-functional alignment between RA, sales, and marketing
Device Type: Class II Medical Device
Challenge: Sales materials contained claims that were inconsistent with approved labeling.
Scope of Review
⦿ Comprehensive review of sales materials
⦿ Assessment of claims alignment
⦿ Standardization of messaging
⦿ Recommendations for material governance and control
Outcome
⦿ Consistent communication across organizations
⦿ Reduced claims compliance risk
⦿ Audit-ready sales materials
12 Sales Material Mistakes That Trigger Compliance Issues in Medical Devices
Field-facing content should be accurate, approved, and consistent before it reaches customers, distributors, or healthcare professionals.
Elexes helps medical device companies establish control, consistency, and compliance across sales materials before deployment.
⦿ Material review kickoff
⦿ Compliance gap analysis
⦿ Constructive/Actionable feedback
⦿ Material refinement support
⦿ Final validation before deployment
Yes. Any material containing product claims should be reviewed before use.
Yes. We review third-party, distributor-created, and partner-developed content.
Yes. We can develop frameworks, procedures, and processes for review.
Claims that are unsubstantiated, inconsistent, outdated information, and poor document management.
Yes. We assist with organizations operating in FDA, EU MDR, TGA, Health Canada, and certain international markets.
A pre-launch review is strongly recommended when materials contain product claims, performance statements, intended-use references, distributor content, or market-specific messaging.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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