Medical devices, including hospital and lab equipment, are critical to patients and the treatment they receive. Thus, it is important for medical device manufacturers to ensure that every product sold meets strict regulatory standards. With that, any sales proposal that involves medical devices should also be compliant, accurate, and error-free. The proposal or quote must clearly provide the product description, visuals, price, and other related information to all parties involved.
As medical devices are highly configurable, maintaining compliance becomes far more complex. This is where the Configure Price Quote (CPQ) software plays a vital role. It ensures that sales teams can quickly create accurate and compliant quotes. In this article, we explore how CPQ helps medical device companies stay compliant.
Compliance in Medical Device Sales
The medical device industry is highly regulated. National agencies like the FDA in the USA and EU MDR in Europe set standards for the organizations operating in the industry. Each country has its own set of rules. These may include specific requirements for configuration options, documentation, and labeling. What is acceptable in one region may be restricted in another. Organizations must follow these standards to ensure regulatory compliance in the sales of medical devices.
As the regulations continue to change and become more stringent, organizations that do not comply may face heavy penalties. It can also damage brand credibility and erode customer trust. This is especially true when selling customized or configured medical devices, where each unique variant may carry different regulatory requirements.
Challenges in Quoting Medical Devices
Creating a quote for medical device sales requires precise documentation and compliance awareness. Relying on manual efforts can make the process ineffective and error prone. Organizations may even have to face issues related to non-compliance.
Mandatory regulatory documentation – Quoting medical devices may require organizations to attach certain certifications or compliance statements to make sure they follow the standards. For example, FDA approval documentation and ISO certification. Missing these regulatory documents can lead to delays in the acceptance or approval of quotes. As a result, organizations may also face customer dissatisfaction or even lost deals.
Complex product and approval workflows – Customers often request discounts or custom bundles. Though sales teams aim to offer custom bundles and discounts to attract customers, they may face intricate rules regarding which products can be sold together and bundling requirements. These proposals may also require legal or managerial approval. Without a structured workflow, approvals may lack an audit trail. This can create compliance gaps during inspections or legal audits.
Traceability – Every product configuration provided in quotes must be traceable. This is to help organizations meet regulatory reporting requirements, audits, or in a situation of a recall. When quotes are managed manually, it becomes difficult to maintain traceability for such events, giving rise to challenges and compliance issues. A compliant system must ensure traceability from quote to delivery.
How CPQ Software Maintains Compliance for Medical Device Manufacturers
CPQ software streamlines and automates the quote process to ensure compliance at every step. Here is how CPQ software enables organizations to keep regulatory compliance when selling medical devices.
Rule-based configurations
CPQ systems use rule-based configurations for products, which automatically enforce compliance. If a combination of product options has not been approved by regulatory bodies, the system will mark it invalid based on the configuration rules. This prevents non-compliant products from being quoted in the first place. Sales teams will only be able to provide quotes with valid product configurations.
Automated compliance checks
CPQ platforms can automate compliance checks in terms of including the required documents, terms, certifications, etc. For instance, medical devices are classified into three categories: Class I, Class II, and Class III. Different quote-related rules can be assigned to the system based on the class of medical devices chosen in the product configuration process. If a product of Class II is selected, the assigned rules will automatically apply. These automated triggers ensure that all required documents and language are included without manual oversight.
Documented approval workflows
CPQ software can integrate approval workflows directly into the system. Any discount or custom configuration can trigger an automatic approval process. Legal, quality, or executive teams can review and approve within the platform. Each action is logged, creating a full audit trail for compliance audits. This automation also helps when it comes to delivering the final quote to the customer for signature.
Compliant quote generation
Quoting medical devices can be difficult and time-consuming due to the technicalities of products and related terms. CPQ solutions make things smoother and quicker by automating the quote generation and management process. The system uses pre-built quote templates to ensure each quote is accurate and meets compliance guidelines. The quote can be generated in seconds with highly precise product descriptions, configurations, and compliance requirements without much human intervention. Sales reps don’t need to create quotes from scratch, which further minimizes the chances of mistakes and improves the turnaround time.
Global compliance
CPQ platforms handle global products and compliance-related requirements easily and effectively. Quotes can be automatically adjusted and updated based on the regions of the customers. The system switches language, currency, measurement units, and regulatory terms as required. This ensures that every quote meets regional compliance expectations without constant human intervention. This further speeds up the approval process.
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Key Benefits of CPQ For Compliance In Medical Devices
Manually managing compliance requirements can slow down the sales process. CPQ software not only makes the process faster but also ensures compliance while accelerating the speed and accuracy of quotes.
- 100% accurate quotes: Quotes generated through CPQ software bring high accuracy and minimize errors. They include all the required elements to help them meet compliance guidelines. Sales teams enjoy minimized risk of errors and non-compliance issues.
- Order accuracy: CPQ software improves order accuracy by ensuring that all quotes are based on valid product configurations and pricing data. This helps sales teams avoid selling non-compliant products to customers, inaccurate pricing, and losing revenue.
- Faster approvals from clients: Sales teams spend days waiting to get final approvals from clients. When customers receive a complete, compliant quote, they are more likely to approve it quickly. There’s no need for excessive back-and-forth to fix missing information or update products or pricing-related details. This leads to faster approvals and quicker deal closure.
- Reduced errors: Errors in sales quotes can be expensive. CPQ solutions minimize the chances of mistakes in quoting by automating the process and fetching data from different systems. CPQ helps medical device manufacturers create more comprehensive and accurate quotes that lead to increased customer satisfaction and faster approvals.
- Peace of mind: Sales teams no longer need to be regulatory experts. Legal teams can trust that quotes align with their policy. Every team can focus on their core responsibilities, knowing the system handles compliance.
How does Cincom help medical device manufacturers stay compliant? Cincom CPQ ensures that every configured medical device and equipment meets the strict regulatory standards set by the FDA and other regional health authorities. Trusted by top organizations in the medical equipment and device industry, Cincom CPQ helps manufacturers reduce compliance risks, prevent expensive errors, and accelerate time-to-market.
Key Takeaways
Though compliance for medical device manufacturers is crucial, depending on manual processes can make the process slower, error-prone, and ineffective. CPQ software allows medical device companies to become effectively compliant while streamlining the selling process of configured medical devices. It automates regulatory rules, ensures valid configurations, and creates audit-ready quotes. Using a CPQ solution, sales reps can move faster, legal teams can ensure compliance, and patients benefit from safe, compliant medical solutions.
In a world where compliance is non-negotiable, CPQ solutions have become more than a sales tool. They have become an asset that lays the foundation for safe, scalable medical device sales.
FAQs
1- How does CPQ software help in configured medical device sales?
CPQ software helps sales teams generate accurate quotes for complex medical devices. It ensures that only compliant configurations are quoted, and all the required regulatory documentation is included.
2- Can CPQ software help with international compliance requirements?
Yes, modern CPQ platforms can enforce country-specific rules and compliance requirements based on regulatory guidelines like EU MDR, FDA, or ISO standards. The quotes can also be updated based on the customer’s region.
3- How does CPQ software ensure that only compliant device configurations are quoted?
CPQ software uses built-in logic and rules to block invalid or unapproved product configurations. It only allows configurations that meet pre-approved (rule-based) compliance criteria.
4- How does CPQ improve audit readiness and traceability in quotes?
Every quote created using CPQ is logged with detailed configuration history, approval workflows, and compliance checks to make quotes traceable and audit-ready.
5- Can CPQ integrate with other systems like CRM or ERP?
Yes, many CPQ platforms can integrate with CRM, ERP, and other sales enablement tools to integrate product data, manage approvals, and ensure end-to-end compliance throughout the process.
6- Is Cincom CPQ especially designed to help complex medical device manufacturers?
Yes, Cincom CPQ is an end-to-end solution that takes care of everything from managing regulatory compliance to handling complex product customization.
