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Efficient processes despite complex regulatory requirements

Many medical device manufacturers face the challenge of implementing regulatory requirements and legal obligations correctly without losing valuable time. Poorly defined processes or incomplete documentation often lead to rework, delays, and issues prior to market entry.

Corscience helps translate complex regulatory requirements into understandable, actionable processes—from quality management systems and risk management to clinical evaluation and regulatory approval. The result is a stable foundation for safe, compliant, and market‑ready medical devices.

How we support your development

MDR-Compliant Quality Management System (ISO 13485)

A structured, ISO 13485‑compliant quality management system forms the regulatory foundation for the development and manufacture of safe medical devices. It reduces risks, optimizes development processes, and ensures compliance with MDR requirements of your medical device.

Scope of Services

  • Implementation workshop (regulatory obligations, roles, and responsibilities)
  • Gap analysis of existing quality management systems
  • QMS development and adaptation
  • Setup of document management systems
  • Integration of QMS processes into existing development, production, and service workflows

Benefits

  • Clear organizational structures and workflows for quality‑relevant processes
  • Increased efficiency in device development and production
  • Promotion of a culture of continuous improvement
  • Full traceability of all relevant activities and decisions
  • Improved risk mitigation through proactive identification and control

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Let’s talk about your requirements.

Supplier Qualification

A structured evaluation and selection of suppliers ensures that external partners meet regulatory requirements and maintain stable, traceable procurement processes. This safeguards the quality of components—and, most importantly, the reliability of supply chains—over the long term.

Scope of Services

  • Training and onboarding
  • Best‑practice workshops (MDR and ISO 13485 requirements)
  • Selection and evaluation of critical suppliers
  • Standards‑compliant implementation of procurement processes
  • Definition and implementation of supplier qualification and release processes
  • Supplier audits and audit planning

Benefits

  • Stable and reliable supply chains
  • Early identification of potential quality and delivery issues
  • Reduced startup challenges in MedTech environments
  • Consistent evaluation and documentation of all supplier‑related activities
  • Confidence in meeting regulatory requirements through structured implementation

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Corrective and Preventive Action (CAPA)

A robust CAPA process increases product quality and reliably fulfills regulatory requirements. Through targeted analysis, weaknesses are identified, corrective and preventive actions are defined, and their effectiveness is systematically verified and documented.

Scope of Services

  • Training and onboarding
  • Gap analysis (assessment of existing processes)
  • Definition, documentation, and tracking of CAPAs
  • Integration of the CAPA process into existing quality management systems
  • Effectiveness checks and continuous improvement

Benefits

  • Reduced audit findings and non‑conformities
  • Avoidance of costs caused by errors and rework
  • Prevention of recurring issues
  • Increased confidence, clarity, and stability within your team

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Regulatory Strategies

A well‑defined regulatory strategy minimizes regulatory hurdles and shortens time to market. It forms the foundation for successful CE and FDA approvals of your medical devices and ensures compliance with complex international regulations from the very beginning.

Scope of Services

  • Regulatory gap analysis
  • CE and FDA approvals, as well as country‑specific registrations (e.g., APAC, MEA, MENA)
  • Definition of regulatory strategies based on device type, target markets, and available clinical data
  • Device classification (risk class, invasiveness, and duration of use)
  • Preparation, coordination, and alignment with notified bodies

Benefits

  • Fulfillment of strict CE and FDA regulatory requirements
  • Reduced time to market for your products
  • Proactive preparation and effective communication with regulatory authorities
  • CE and FDA certification and market access to additional regions
  • Strategic regulatory know‑how built within your team

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Clinical Affairs

Clinical Affairs provides the foundation for well‑informed regulatory decisions and continuous product safety. Through systematic planning, collection, and evaluation of clinical data, regulatory approval, post‑market surveillance, and product optimization are closely linked.

Scope of Services

  • Clinical evaluation (collection, analysis, and documentation of clinical data)
  • Planning of clinical studies and study design development
  • Ethics committee submissions
  • Preparation of Clinical Evaluation Reports (CER)
  • Implementation of Post‑Market Surveillance (PMS)
  • Post‑Market Clinical Follow‑up (PMCF)
  • Preparation of Periodic Safety Update Reports (PSUR) and Summary of Safety and Clinical Performance (SSCP)

Benefits

  • Valid evidence of clinical safety and performance
  • Complete and traceable clinical evidence
  • Early identification of data gaps by experienced experts
  • Standards‑compliant documentation for notified bodies

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EU AI Act

The EU AI Act defines new requirements for the safe and legally compliant use of artificial intelligence systems. A systematic classification and implementation of these requirements is essential to avoid regulatory risks for your products and to adapt existing quality and development processes at an early stage.

Scope of Services

  • Training and onboarding
  • Adaptation of existing development and quality management processes to AI Act requirements
  • Regulatory alignment with existing applicable standards and regulations
  • Assessment and risk classification of AI systems in accordance with the EU AI Act

Benefits

  • Reduced regulatory risk through early process adaptation
  • Clearly defined roles and responsibilities
  • Proactive preparation for future regulatory developments
  • Establishment of modern, future‑proof processes

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Risk Management

In medical technology, systematic risk analysis is a legal requirement and a key element of patient safety. A clearly defined risk management process enables consistent assessments, effective risk control measures, and regulatory compliance throughout the entire product lifecycle.

Scope of Services

  • Training and onboarding
  • Gap analysis of existing processes
  • Establishment of standardized risk management processes
  • Definition of responsibilities, methods, and evaluation criteria
  • Verification of effectiveness
  • Risk management in accordance with ISO 14971:2019

Benefits

  • Clear assessment criteria and well‑documented decisions
  • Systematic identification and control of potential hazards
  • Standardized risk management files with defined measures and evidence
  • Seamless integration into CAPA and PMS processes, enabling continuous monitoring

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Let’s talk about your requirements.

Technical Documentation

Complete and standards‑compliant technical documentation is a prerequisite for regulatory approval and market placement of medical devices. It ensures that the design, manufacturing, and safety of your products are transparently documented, traceable, and verifiable for regulatory review.

Scope of Services

  • Gap analysis of existing technical documentation
  • Review of applicable standards for currency and relevance
  • Development of the technical file (device description, specifications, functions, and intended use)
  • Design decisions, risk assessments, and verification and validation
  • Labeling, instructions for use (IFU), and service documentation

Benefits

  • Optimized foundation for regulatory approval and market release
  • Complete and traceable documentation of development, changes, and testing activities
  • Consistent structure and version control across all documents
  • Full traceability of design decisions and verification activities

Contact

Let’s talk about your requirements.

Documents and Templates

Creating regulatory‑compliant documentation is complex and time‑consuming. Product‑specific templates, combined with expert guidance, reduce documentation effort and help accelerate your development processes.

Scope of Services

  • Building blocks for requirements specifications (requirements, applicable standards list)
  • Sample PCB inspection instructions for defibrillation boards
  • Template final inspection instructions for an AED
  • Excerpts from hardware FMEAs
  • Excerpts from risk analyses
  • Template for intended purpose and device classification (AED)
  • Sample EMC test plan for an AED

Benefits

  • Faster creation of regulatory‑required documentation
  • Proven, experience‑based, and validated templates
  • Expert support and close collaboration during implementation
  • Prevention of documentation gaps through validated document structures

Contact

Let’s talk about your requirements.

Our Service Packages for Your Success

Drawing on experience from numerous MedTech projects and close collaboration with leading manufacturers and startups, we offer tailored service packages designed to bring your medical device development to its goal faster, safer, and with confidence.

MDR Approval

We review your documentation, identify gaps, and support implementation for a safe, predictable market entry that meets regulatory requirements.

Package Details

Clinical Evaluation

We collect, analyze, and prepare data in a standards‑compliant manner across all risk classes. This ensures approval, compliance, and trust in your product.

Package Details

Supplier Qualification

We support supplier selection, audit programs, and implementation—for standards‑compliant processes, documented quality, and stable, reliable supply chains.

Package Details

CAPA360

We analyze root causes, define corrective and preventive measures, and and make success measurable, ensuring effective and transparent, and regulatory‑compliant processes.

Package Details

AI Act

We prepare your team for the new EU requirements in a clear, hands‑on, and industry‑specific way—ensuring compliant AI development and long‑term regulatory confidence.

Package Details

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Working with Corscience has been a great help in the development of MD Start’s very early stage medical device ideas. Their speed, responsiveness and extensive knowledge in the field has helped us advance our projects rapidly and efficiently.

Tim Lenihan
Contract Medical International

The project has really ambitious goals, in terms of timeline and technology. Together with the Corscience team, we succeeded in defining the requirements in a way that can make it possible. In the process, we’ve learned what it means to implement a system architecture and software for a safety-critical system. The collaboration was always at eye level and with a holistic view of the project – we couldn’t have asked for more from a development partner.

Sascha Kuns
enmodes

We have integrated the CAP201 into our ventilation products and are more than satisfied with the performance of the module and the customer-oriented cooperation with Corscience. The module’s interfaces are simple and intuitive, allowing for a hassle-free integration process. […] But especially its reliability is a standout feature for us, as we have encountered minimal customer complaints or field incidents. We will therefore continue to work closely with Corscience on future projects, using their great modules.

Andreas Sommer
WEINMANN Emergency

Many of our customers are still using the DM200. They love the device for its reliability, stable Bluetooth connectivity, light weight and small size, and especially for its features such as real-time 12-lead ECG streaming, remote blood pressure measurement and SpO₂ measurement. We are very pleased that Corscience has worked with us to develop this robust and extremely reliable device.

Trong-Nghia Nguyen-Dobinsky | Managing Partner
GHC Global Health Care

Corscience proved to be an exceptional partner, not only because their module met most of our technical requirements, but also because of their proactive approach to addressing critical safety questions from the outset.

| Technischer Projektleiter
NASA

Corscience supported us in the development of the extracorporeal drive unit for our reBEAT cardiac support system. Thanks to their expertise in system, hardware and firmware development as well as their extensive process experience, all project goals were achieved and our internal processes were optimized. This and the overall very cooperative partnership enabled a smooth handover of the project to our development teams.

Johannes Clauss | CTO
Adjucor

We are glad to have an experienced service provider like Corscience by our side, who have such comprehensive technological and regulatory expertise.

Jacob Christensen
Joule Medical

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