Quality & Risk Management for Medical Technology

Full Compliance for Medical Technology

Always ready for MDR, IVDR, ISO 9001, ISO 14971, ISO 13485, and FDA requirements.

Stay ahead of regulatory requirements with a future-proof quality and compliance strategy:

Quality Management: ISO 9001, ISO 13485
Risk Management: ISO 14971
Regulatory Compliance: EU MDR, EU IVDR, FDA 21 CFR Part 820
Audit & Approval Readiness: End-to-end documentation and validation

Your Challenges

What puts your quality at risk

High validation effort and strict GxP requirements drive up costs.

Implementing quality-related software systems in the medical technology industry requires significant validation effort. Documentation, compliance evidence, and adherence to GxP guidelines under GAMP 5 are particularly cost-intensive.

Complex regulations (MDR, FDA) delay time-to-market.

The growing number of regulatory requirements and lack of transparency in documentation processes lead to delays and make audits more difficult.

No seamless risk management = no structured product development.

In many companies, risk management is not fully integrated into the development process. Missing traceability between requirements, risks, test planning, and actions makes it harder to comply with ISO 14971, FDA Design Control (21 CFR 820.30), and MDR. This results in inefficient reviews, increased coordination efforts, and incomplete risk documentation.

Incomplete use of field data limits risk assessment and CAPA.

Post-market surveillance is a key element of regulatory frameworks like EU MDR and FDA 21 CFR Part 820. Without end-to-end data transparency, structured evaluation, and traceability, critical field signals go undetected – increasing safety risks, liability exposure, and audit or recall costs.

Fragmented tools without data consistency threaten compliance and audit readiness.

Siloed systems and media discontinuities prevent consistent analysis of interdependencies. Ensuring and proving quality and compliance becomes time-consuming and inefficient.

Our Solutions

How to connect development, compliance, and market requirements

Secure & GAMP 5-compliant documentation.

We meet all regulatory requirements for use in GxP environments – such as medical device or pharmaceutical development. Our GAMP 5-compliant solution includes all necessary validation documents, forming the foundation for efficient compliance with MDR, ISO 13485, and FDA 21 CFR Part 11.

GAMP 5-compliant solution

Integrated DMS for SOPs, QMS, and technical documentation.

Our document management system (DMS), as part of the eQMS, provides a centralized platform for structured, version-controlled management of all quality- and compliance-related documents – from SOPs to technical files. Existing management systems (e.g. ISO 13485, GxP) can be seamlessly integrated, harmonized, and efficiently controlled – fully traceable and 21 CFR Part 11 compliant.

Document management in eQMS

End-to-end eQMS with integrated CAPA logic for full audit readiness.

Our quality management system ensures complete documentation of tests, statistics, audits, and certifications – including consistent implementation of CAPA methodology. This enables long-term quality assurance and sustainable regulatory compliance.

Manage CAPA processes efficiently

Integrated risk management in line with ISO 14971 – directly linked to requirements, tests, and measures.

Our solution connects risks directly to design inputs, verifications, and mitigation measures across the entire product lifecycle. Risk analyses such as FMEA, hazard analysis, or fault tree analysis are systematically managed through a central platform – fully compliant with ISO 14971 and ISO 13485 design control.

Manage risks consistently

Integrated post-market surveillance with end-to-end CAPA integration.

As part of post-market surveillance (PMS), you capture and assess all relevant field data – from customer complaints and incidents to service feedback. Direct linkage to CAPA management ensures traceable documentation and tracking of corrective and preventive actions. All compliance records are available at the push of a button – always audit-ready.

PMS with complete CAPA logic

Your Benefits

Your competitive advantages at a glance.

Accelerate Development, Minimize Risk, and Ensure 100% Compliance – Globally

Achieve validated solutions up to 30% faster. Be audit-ready with a fully documented system foundation. Speed up your validation processes through structured, traceable system components – enabling compliant product launches with reduced effort and increased inspection reliability.
Less effort. More control. Full compliance. Centralize all quality-relevant documentation in one system to eliminate redundancies, reduce audit workloads, and create a lean, end-to-end traceable documentation structure across all regulations and standards.
Lower cost of errors. Reduced testing effort. Maximum audit readiness. Systematically prevent errors and sustainably lower audit and inspection costs – powered by validated data, consistent processes, and a centralized knowledge base.
Complete risk transparency and egulatory compliance – Without extra effort. Reduce time spent on reviews, audits, and approvals with connected risk and development data. Close gaps in risk management, enhance product safety, and meet regulatory requirements efficiently – saving up to 40% of time on risk analysis and documentation.
Fewer recalls. Greater safety. Lower costs. Structured evaluation and implementation of regulatory measures significantly reduce risk and error-related costs. Improved data quality enhances risk visibility, lowers audit workloads, and accelerates market response. Increase product safety, minimize compliance risks, and secure your market position long-term.

Audit Security

up to

Faster Time-to-Validation

up to

Time Savings in Analysis & Documentation

Regulatory Compliance

Transparency

up to

Reduction in Data Maintenance Effort

From start-up to enterprise

Trusted by our customers.

Customer Testimonials

Voices of Our Customers

Discover what our customers have to say about using our software and how our solutions have helped them achieve their goals and secure their success.

"We need a continuous traceability and this is simply great to realize with XERI. The documentation, such as the design dossier and regulatory requirements – which are no less stringent can be optimally mapped and provided. Since we are not only active on the European market, but also on the Asian market and in the USA, we need such requirements. With XERI, we are networked worldwide with our sales companies, and that works well.“

Bärbel Müller, Quality Management, Waldemar LINK GmbH & Co. KG

"Thanks to the seamless integration into our IT application landscape, we’ve been able to unlock the full potential of the PeakAvenue CAQ Suite.”

Wolfgang Werz, Head of IT, Erbe Elektromedizin GmbH

"With PeakAvenue, we found a transformative solution that has revolutionized our quality management and manufacturing processes. The web-based platform has helped us increase our efficiency and elevate the quality of our products to an entirely new level. We’re excited about the future that PeakAvenue has made possible for us.”

Dr. Arno Antlitz, Finance and Operations

We are here for you. Contact us.

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QMS Solutions for Medical Technology – Secure, Compliant, and Audit-Ready

Always ready for MDR, IVDR, ISO 9001, ISO 14971, ISO 13485, and FDA requirements.

What puts your quality at risk

High validation effort and strict GxP requirements drive up costs.

Complex regulations (MDR, FDA) delay time-to-market.

No seamless risk management = no structured product development.

Incomplete use of field data limits risk assessment and CAPA.

Fragmented tools without data consistency threaten compliance and audit readiness.

How to connect development, compliance, and market requirements

Secure & GAMP 5-compliant documentation.

Integrated DMS for SOPs, QMS, and technical documentation.

End-to-end eQMS with integrated CAPA logic for full audit readiness.

Integrated risk management in line with ISO 14971 – directly linked to requirements, tests, and measures.

Integrated post-market surveillance with end-to-end CAPA integration.

Your competitive advantages at a glance.

Trusted by our customers.

Voices of Our Customers

We are here for you. Contact us.

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