Services for Manufacturers

We have carefully analyzed the challenges manufacturers face in relation to analytical quality control.

Manufacturers must ensure that their solutions are implemented reliably, that they comply with international regulations, and that users understand the strategic role of quality control in their daily operations.

We understand that ISO recommendations and CLSI documents establish that the use of independent control materials is the most robust practice to ensure reliable results and minimize clinical risks.

However, translating these recommendations into practices adopted by distributors and end customers isn't always easy. This is where APEX provides unique value.

We have designed a suite of services for manufacturers that comprehensively address these needs.

Our services allow:

• Promote the adoption of Quality Control, integrating it into the manufacturer's value proposition and preventing it from being perceived as an optional extra.

• Generate solid technical evidence and documentation that supports performance statements, facilitates accreditation, and positions the brand as a scientific benchmark.

• Offer post-market support and educational ecosystems that strengthen relationships with distributors, end customers, and regulators, positioning the manufacturer as a thought leader.

The result is a services framework that transforms Quality Control into a tangible competitive advantage.

With APEX, manufacturers not only comply with international regulations, but also project confidence, educate the market and consolidate long-term relationships with their clients and strategic allies.

In the following sections, you'll discover how each service is designed to address critical manufacturer needs, strengthening both their commercial impact and scientific prestige.

Service Group A:

Adoption and Communication of the Value of Control

Manufacturers who get their distributors and internal teams to talk about Quality Control as an integral part of the system make an immediate difference in the market.

It's not just about selling an essay or an instrument: it's about showing each client that true strength comes from reliable results.

These services impact both the distributors representing the manufacturer, or their sales and marketing teams, and the end customers they serve.

• Turn distributors into prepared spokespersons, capable of transforming a technical argument into a strategic message that directly impacts the purchasing decision.

• For the end customer, it means security and support; for the manufacturer, it means loyalty, increased adoption, and differentiation.

1. Market Adoption and Channel Enabling in Control

We train manufacturers' internal teams to communicate the value of Quality Control as an essential part of the system, transforming it from an ancillary requirement to a strategic argument that drives adoption and brand loyalty.

Features:

• Technical and commercial support materials focused on internal or independent quality control.
• Training on key messages and common objections for internal teams and end customers.
• Use cases linked to international and local standards and audits.

Value for the distributor:

• Increases adoption of the Recommended Control, integrating it as a natural part of the offered system and providing manufacturers with an essential monitoring tool to analyze behavior, assess risks, determine costs, and improve processes in the medium and long term.



• Strengthens competitive position, reducing leakage and consolidating brand adhesion.

Service Group B:

Technical Excellence and Operational Evidence

"Scientific credibility" is the name of the game.

Integrating Quality Control into risk strategies, verification kits, and evidence studies makes each product an irrefutable proposition.

This service group enables its representatives to deliver a system that is defensible in audits, accreditations, and before any regulatory body.

The impact is twofold and decisive:

• Customers are provided with clear tools to demonstrate performance, which translates into trust and continuity.

• For the manufacturer, this building block is the key that turns each implementation into a verifiable success story, reinforcing performance claims, accelerating adoption, and differentiating the brand from competitors that lack the same scientific foundation.

2. Integration of risk-based quality control

We design control strategies aligned with ISO and CLSI, integrating statistical control and frequencies tailored to clinical risk. The manufacturer delivers a robust, defensible, differentiated, and fully traceable technical proposal.

Features:

• Risk matrices applied to tests, processes and instruments.
• Designing performance-based strategies, optimizing costs and managing risk.
• Technical documentation to reinforce quality and reliability claims.

• Value for the distributor:

• It reinforces the robustness of its portfolio, demonstrating its ability to engage with its users' Quality Management Systems as a crucial part of analytical system design.
• Differentiate yourself from your competitors by demonstrating operations at a higher standard.

3. Training and design in Verification of analytical methods.

We form teams and create CLSI-based verification protocols, facilitating the production of evidence that clients can use to validate system performance and simplifying their accreditation processes.

Features:

• Protocols adapted to different laboratory environments.
• Provision of information in documentable formats and audit-ready reports.
• Practical guides for interpreting results and acceptance decisions.
• Training of representatives capable of providing support and designing internal protocols.

Value for the distributor:

• Facilitates successful implementations, reducing friction and adoption time.
• Prevents wasted resources by managing robust and documented qualification tasks, resulting in reliable, efficient, and cost-effective verification exercises for both parties.
• Increases customer and auditor confidence, supporting system robustness.

4. Evidence Generation and Objective Assignment

We design and execute performance studies to support performance claims such as commutability, stability, and performance. We deliver technical reports, produce publications, and valuable materials for scientific marketing, while identifying and developing thought leaders.

Features:

• Equivalence and commutability studies with recognized controls.
• Planning traceable and defensible analytical objectives.
• Scientific documentation and dissemination materials validated by the control community.

Value for the distributor:

• Strengthens regulatory and commercial arguments with objective and independent evidence.
• It boosts brand prestige by positioning it as a scientific benchmark compared to the competition, maintaining the momentum and credibility that comes with the backing of the concept of quality.

Service Group C:

Expert Intervention and Strategic Education

Offering unbiased response protocols based on evidence produced by Quality Control, while fostering and promoting a robust, permanent, and consistent educational ecosystem, are actions that build the future of your market and its longevity over time.

The after-market support service turns every out-of-control event into an opportunity to strengthen relationships with premium customers, demonstrating that the brand doesn't give up, but rather responds with science and agility.

The educational ecosystem, for its part, extends the manufacturer beyond the product: it positions it as a thought leader in quality control.

The result goes beyond visibility:

• Customers perceive that they are not just purchasing a system, but rather a strategic partner that elevates their own performance, compliance, and competency.

• The brands represented consolidate their image as an ally involved in the training of their clients, leading them to excellence with scientific support and a commitment to the growth of healthcare professionals for the benefit of the population they serve.

5. Efficient Response Algorithms and Escalations

We structure response protocols for out-of-control events based on evidence produced by quality control, ensuring impartial and documented analysis. This protects the manufacturer with clients and auditors, strengthening their reputation in critical situations, while securing resources and prestige.

Features:

• Standardized response playbooks with escalation paths for internal and external customers.
• CAPA processes with evidence supported by structural control practices.
• Integration of technical feedback to the internal customer.

Value for the distributor:

• Reduce reputational impact in critical incidents with fast and reliable solutions.
• Rational, focused, and efficient deployment of care, preventing the waste of valuable resources and avoiding the undermining of customer and regulatory trust by using objective evidence.

6. Educational Ecosystem and Scientific Content for the Manufacturer

We develop educational programs and content libraries that focus on control knowledge. This allows manufacturers to educate the market, accelerate adoption, and position themselves as thought leaders in the IVD industry.

Features:

• Train-the-trainer programs for specialists, salespeople, marketers, and distributors.
• Production of scientific materials, from guides, infographics, and videos to webinars.
• Editorial calendars and thematic campaigns with a focus on quality control.

Value for the distributor:

• Increase adoption and confidence in your systems thanks to better-trained customers.
• It reinforces brand leadership, projecting it as an educational and scientific benchmark.