Design Control for Safe Product Development

Challenge

When Lack of Transparency Becomes a Development Risk

In medical device development, well-structured documentation is critical to product safety, regulatory approval, and time to market.

Yet many companies struggle with isolated, inconsistent data and an unclear flow of information between development, quality, and regulatory affairs.

The lack of transparency across the entire product lifecycle leads to time-consuming rework, increased audit risk, and delayed market launches.

Incomplete traceability: Data is often scattered across separate documents or systems. Limited visibility between user needs, design inputs, and verification and validation activities slows decision-making and increases project risk.
Hidden interdependencies: Risks, controls, and product functions are interconnected. These relationships are often not identified early enough.
High documentation effort: Creating technical documentation for regulatory approvals is time-consuming and ties up valuable development resources.

Companies that rely on fragmented design control processes instead of a centralized system risk project delays, rising costs, and delayed regulatory approvals.

Solution

Control Product Development with Full Transparency

With our Design Control software, you maintain complete visibility across your entire product development process.
The integrated traceability matrix ensures end-to-end traceability between user needs, requirements, design outputs, risks in accordance with ISO 14971, and verification and validation activities — auditable and compliant with ISO 13485, EU MDR, EU IVDR, and FDA Design Control requirements under 21 CFR § 820.30.

Design changes? No problem.
With just a few clicks, you can see which requirements, tests, or risks are affected — enabling fast impact analyses and a secure design transfer.

Integrated risk management: Risk control measures are incorporated directly into development planning as design inputs, helping teams make informed decisions and identify critical issues earlier.
Improved communication: A consistent, end-to-end process that clearly links risks, requirements, and controls simplifies coordination and collaboration across teams.
Rapid updates: Centralized data management allows your team to make changes or additions quickly, without creating inconsistencies.
Reliable action tracking: All actions are managed centrally to ensure nothing is missed and all evidence remains complete and auditable.
Efficient knowledge management: Structured, centralized repositories, reusable content, and clear reporting make organizational knowledge sustainably accessible.
Increased efficiency: Automated reports and linked documentation reduce manual effort and accelerate regulatory approvals.

A powerful Design Control software solution establishes clear structures and supports a safe and efficient development process in medical technology.

Benefits

Key features at a glance

Centralized Design Control Management

All user needs, requirements, functions and specifications, design outputs, risks, and verification and validation activities are systematically linked and available to you at any time.

Template and Knowledge Management

Templates, lessons learned, and structured repositories are centrally available, accelerating recurring development processes.

Integrated Risk and Action Management

Requirements, product functions, risks, and risk control measures are tightly linked, enabling early identification of dependencies and impacts.

Traceability Management

Relationships from user needs through validation are systematically mapped to ensure full traceability of development data.

Graphical System Analysis

Automatically generated diagrams and visual overviews provide clarity and support informed decision-making.

Web-Based Application

Browser-based access enables easy use, high availability, and efficient collaboration across locations and teams.

SCREENS

Clear structure and intuitive operation

Softwarescreen Design Control Traceability Matrix — Traceability Matrix – Technical Requirements, Design Outputs, and Design Verification

Software screen Traceability Matrix with user requirements — Traceability Matrix – User Requirements, Risk Controls, and Design Validation

Software screen Traceability Matrix Links in the requirements network — Traceability Matrix for the tabular representation of the links within the requirements network

Our Brands

Quality at the highest level

The PeakAvenue platform combines the strengths of leading expert systems from APIS IT, PLATO, iqs Software, Isograph, and OSSENO Software into an integrated solution for end-to-end engineering and quality management.

Our current software solutions will remain available and will be supported in the long term, while future innovations will be incorporated into the PeakAvenue platform—ensuring a secure, step-by-step transition to a modern, networked software world.

PeakAvenue Plattform

Expert solutions united in one eQMS

The central basis for the quality and development of your products: Seamlessly connect tools, data, and processes for maximum transparency and efficiency throughout the entire product lifecycle.

Quality Center

End-to-end QMS software for long-term quality excellence

Achieve measurable, transparent quality improvements: iqs QC covers the complete quality control cycle - from planning and shop-floor inspection to in-depth analysis.

e1ns Engineering

Optimize product development and quality

Secure product quality from the very beginning: With PLATO e1ns, you manage your development process efficiently and reduce risks—web-based, structured, and fully integrated.

IQ Software

Your benchmark for FMEA and Risk Analysis

Achieve top-tier FMEA and risk analysis: APIS IQ-Software enhances your process efficiency and ensures lasting functional safety and quality.

Isograph RAMS

Expert software for RAMS and Fault Tree Analysis

Master complexity in reliability, safety, and availability: Isograph’s advanced tools empower companies to accurately evaluate and optimize complex systems.

reqSuite® rm

Efficient, intelligent requirements management

Streamline your requirements management - simpler, more structured, and more efficient: reqSuite^®rm from OSSENO Software delivers a top-tier solution that is intuitive, powerful, and enhanced with smart assistance.

Implement Product Development Safely and Efficiently with Design Controls

Learn how our Design Control software structures development and supports regulatory approvals.

Design Control Software for Safer Product Development