How digital product processes make medical technology more efficient – with OMN from apollon
PRODUCT EXPERIENCE MANAGEMENT
Medical technology is one of the most demanding industries in the world – every second, every regulation and every line of data counts. But while products are becoming increasingly innovative, many companies continue to struggle with inefficient processes, scattered data and time-consuming coordination between teams.
This is where apollon comes in: we help medical technology companies optimise digital product and content processes – securely, systematically and efficiently.
Challenge: Complex data and high requirements
Whether product data sheets, approval documents or marketing materials – in medical technology, all content must be accurate, up to date and compliant. However, this information is often scattered across Excel lists, network drives or various tools.
This leads to:
- Duplicate work for approvals and corrections
- Time lost due to manual reconciliation
- Prone to errors, which increases compliance risks
Solution: Structured product data with OMN
With OMN, companies create the basis for efficient, secure and traceable workflows.
Our platform ensures that:
- All product and media data are managed centrally
- Approval processes are digitally controlled and documented
- Marketing and sales teams can respond more quickly
This transforms a confusing data landscape into a clearly structured flow of information – from the laboratory to the landing page.
The advantages at a glance
1. Greater efficiency in everyday work: fewer manual reconciliations, less duplication of work.
2. Higher data quality & compliance security: apollon ensures that product information is always up to date and correct – and that MDR and ISO requirements are met.
3. Shorter time to market: Marketing materials, product sheets and web content can be created, approved and published more quickly – without compromising on quality.
4. Transparent processes: All workflows – from product development to approval – are documented in a traceable manner. This allows you to maintain an overview at all times.
5. Future-proof scalability: apollon grows with you: Whether you have new products, markets or partners, the system remains flexible and powerful.
Why apollon?
OMN is not a standard tool, but a solution for digital process optimisation in regulated markets.
We understand the special requirements of medical technology – from MDR to ISO-compliant documentation – and develop solutions that:
- Secure and compliance-ready
- Seamlessly integrate into existing systems
- Simplify processes in the long term
Regulatory framework in medical technology: what OMN specifically supports
Medical technology is one of the most heavily regulated industries in the world. Since the full application of the EU Medical Devices Regulation (MDR 2017/745), significantly stricter requirements apply than under the predecessor directive MDD — with considerable consequences for manufacturers’ product documentation obligations.
MDR and IVDR: what this means for product data
The MDR requires manufacturers to maintain complete technical documentation for each medical device placed on the market. This includes, among other things:
- Complete descriptions of the product and its intended purpose
- Evidence of conformity with the general safety and performance requirements
- Instructions for use in the languages of the target markets (Article 10, Annex I MDR)
- Traceability of all product versions and changes (UDI system)
- Post-market surveillance documentation
Similar requirements apply to in vitro diagnostics under the IVDR (2017/746). Added to this are requirements from ISO 13485 (quality management systems for medical devices), which prescribe structured processes and traceable documentation of product changes.
The problem in practice: Many MedTech companies still manage this documentation in fragmented systems — instructions for use in DMS, product specifications in ERP, marketing copy in CMS and images on network drives. Every change to a product must be manually transferred to multiple systems — with high error risk and without an automatic audit trail.
How OMN supports MDR documentation obligations
Central versioning of all product documents: Instructions for use, safety notices, technical drawings and certificates are stored with version control in OMN DAM. Each new version clearly supersedes the previous one — with timestamp and user assignment. The complete version history is available at any time for audits.
Multilingual documentation from one source: MDR-compliant instructions for use must be available in the official languages of the sales markets. OMN manages translations as language variants within the same data object — changes to the source language are automatically routed into the workflow as translation tasks. This ensures that no language version becomes outdated.
Approval processes with audit trail: Changes to safety-relevant product data pass through configurable approval workflows in OMN — for example: specialist department reviews, Regulatory Affairs approves, QM releases. Every step is documented with timestamp and user. This corresponds to the requirements for a traceable change history under ISO 13485.
UDI integration: The Unique Device Identification (UDI) system under the MDR requires unique product identifiers that must be communicated consistently across all channels. OMN can map UDI data as a standardised attribute in the product data model and distribute it consistently across all output channels — packaging, website, marketplace.
Concrete use cases: where OMN makes the biggest difference in MedTech companies
Use case 1: Product approval in new markets
A MedTech company wants to introduce an existing product into three new EU markets. This requires instructions for use in three languages, country-specific declarations of conformity and adapted packaging designs.
Without structured product data management: Several weeks of coordination between Regulatory Affairs, translation agency, marketing and printers — with many email loops and the risk of outdated text versions going to print.
With OMN: The source product is already fully documented. Translation tasks are issued directly from OMN to external service providers, returns land back in the system as language variants and automatically pass through the approval workflow. The finished packaging design accesses the approved assets directly via CI HUB.
Use case 2: Safety-relevant product change
A change to a medical device requires an updated safety warning in the instructions for use — immediately in all sales countries.
Without OMN: Manual notification of all country organisations, manual updating of the website, print materials and dealer portals. High risk that individual markets are forgotten or that outdated versions continue to circulate.
With OMN: The change is made once in the master version, the translation workflow starts automatically, and after approval all output channels are updated. The audit trail documents comprehensively when each market received the updated information.
Use case 3: Digital Product Passport (DPP)
From 2027, the EU Ecodesign Regulation introduces the Digital Product Passport (DPP) — initially for selected product categories, with a perspective of expansion to medical devices as well. The DPP requires machine-readable, structured product data on material composition, repairability, disposal and conformity — accessible via a digital data carrier.
OMN, as a central product data platform, is the natural foundation for DPP data: structured attributes, document linking and open interfaces enable the transfer of relevant data to DPP-compliant registration platforms — without redundant data maintenance in yet another silo system.
Bills of materials, product configuration and complex product hierarchies
Many medical devices are not simple individual articles but systems consisting of multiple components — with different variants, accessories and optional extensions. Technical documentation must cover every configuration option.
OMN supports hierarchical product structures and variant management: components are created as independent products with their own documentation and linked to the parent product via relations. Changes to a component automatically propagate to all parent products — and trigger an approval workflow there if necessary.
Differentiation: why standard PIM solutions often fall short in regulated markets
Many PIM systems are primarily designed for retail — fast distribution to online shops, marketplaces, printed catalogues. Simple attributes and export functions are sufficient for these use cases.
MedTech companies need more:
- Traceable change history with user and timestamp (audit trail)
- Configurable approval workflows for regulated content
- Versioning at document level (not just at data field level)
- Roles and rights model that cleanly separates Regulatory Affairs, QM and Marketing
- Multilingualism as a structural feature, not an export function
OMN provides these functions as integrated components of the platform — not as retrofitted add-ons.
Summary
EffizEfficient processes are the key to innovation – especially in medical technology.
With apollon, you not only bring order to your product data, but also free up time for what really matters: progress and quality.
Do you know our PIM and DAM?
CONTACT US WITHOUT OBLIGATION AND LET US CONVINCE YOU OF OUR OMN.