ISO 13485 ISO 14971 IEC 62304 21CVR 820 VDI 5702 MSPICE®

Deutscher Mittelstand Template

Life Science developments is taking the opportunities derived from new development. From the new capabilities of sensors, new materials or AI. With all those new technologies, in conjunction with the constantly request for higher quality you need a can get lost in the sheer amount of what is required to develop a medical device that will stand a formal audit by the authorities. Deutscher Mittelstand for years has been a proven partner in the development of normative regulated products. (Aerospace, Automotive, Industrial, Legal, Life Science) Having been on the “war zone” of the product development and maintenance, is it task force, project, quality or interim management, we are familiar with the challenges, constraints and pitfalls. Our principal assessors, guided us further. We have combined the know-how from various domains and developed a template that suits the needs as requested by various standards. The Life Science Template contains “all you need” to evidence

compliance with the various standards that you need to follow. Working with this template, your compliance with the various Standards IEC 62304, alternatively VDI 5702 Medical SPICE® ISO 13485, ISO 14971, as well as IEC 60601 and Title 21 CFR Part 11 (FDA) can be easily achieved. Kovair ALM not only provides the full functionality of a complex ALM solution. From the project view:

Is it project-, risk-, quality-, requirements-, architectural-, development-, test- and

integration-management. Kovair covers it all.

Kovair unique design with its “omnibus” and more than 90 existing adapters with a detailed synchronization allows you to integrate your existing toolchain and archive data-consistency throughout the full lifecycle.

Break Down your Work and Monitor

No Plan will survive the first contact with real life but if made well, a plan eases the execution of a project. Multiple plans can exist in a project – for each domain

The template is loaded with preconfigured content derived from real life projects.

• Change Management Plan • Configuration

Management Plan • Documentation

Management Plan • Problem Management

Plan • Project Cost Estimation • Project Management

Handbook

• Project Plan • Quality Management Plan • Resources Management Plan • Safety Plan • Software Development Plan • Software Maintenance Plan • SW Unit Test Plan • Validation Plan

Are these items all preconfigured with artifacts. If you don’t need, you can cut, if you need, just adapt and run.

You interconnect all plans according to your needs.

Monitoring resources is crucial in a project. Kovair’s unique cross project resources monitoring will show you the resource allocation within of your project and conflicts to other projects. Wherever you are you will see what is happening with your plans and your resources. Overallocations will be made visible and you can take corrective actions before the problem arises.

The project calendar will keep everyone a quick glance of what is happening in the project.Tasks that are in the System can be viewed with a glance.

synchronization with your other during runtime Kovair not only synchronizes with MS Project, but with more than 90 tools. Whatever you use – it’s getting synchronized.

“All of a sudden” you can have data consistency across your toolchain. No need to constantly run around and ask for a state of affairs. You will see what is happening!

Kovair ALM is designed to enable you built Medical Devices by

“Just do your Job” And therewith create and evidence compliance to the respective standards IEC 62304, ISO 14971, ISO 13485, 21 CFR 820……

Plans, resources, quality, checklists, requirements, design entities, test, configuration, risk and change management features and all artifacts are preconfigured for medical processes to ensure full traceability and auditability throughout the complete development lifecycle.

Predefined

You can use our proven processes(what requires additional consulting time). We will adapt to what you need in your company and will have a working robust process house that will typically withstand any audit. Reuse practices and robust processes help you cut development and verification time and costs.

Process Management Configuration Define your own processes, enforce compliance and monitor execution as it happens. Design and execute your workflows to meet the needs of your development. Any process that you define i.e as can be seen above can be implemented

Requirements Management

Clinical / medical needs entities, system-, software-, hardware and architecture related entities are predefined to capture and manage all requirements of the medical device, the respective standards and . Traceability settings – predefined, including full Change impact analysis, based on individual configured impact effects shows the dependencies top down and bottom up across plans, requirements, gates, tests and risks. You define Kovair delivers the data A Coverage Browser helps make sure that all your requirements are covered with test cases.

Review

Review (which may be purchased as an add-on) is a powerful tool that supports compliance audits. It enables you to collect and assign work items for review and review all changes as well as the impacts of these changes conveniently. Auditors can easily trace changes to specifications and review all the actions resulting from these changes. Statistics may be simply exported. Use the Review to manage approvals of all changes to customer specifications with all their relations, and trace their implementation through to testing with minimal effort.

Basis • Defines relationships between artifacts

with cardinality • Supports Vertical Traceability • Reports have drill-down capabilities • Configurable business rules for performing

event based, schedule based, escalation and validation-based actions.

• Configurable notification templates • Configuration through mouse clicks • Version Diagram allows side by side

comparison between any two versions • Support for Text search, ID search as well

as Smart Search • Support for Multi-level Group By views are

available • Kovair provides custom Word Addin directly

through MS Word interface

Task management • Task Based Workflow • Eliminates manual handoff with combination of

tasks and notifications • Supports for both Micro and Macro level workflow • Synchronize cross artifact workflows enabling

central co-ordination • Supports parallel workflow activities with

conditional branching • Supports automated actions prior and post of any

activity defined in the workflow • Supports multiple versioning of the same

workflow • On Release of your plan tasks get created

automatically

Document Management

• Any document that you import into Kovair – i.e. a customer specification is directly as well stored as a document in the document Entity, that you define.

• Any another document you can get in, keep under Version and configuration control

Release Management

• Release Management in Kovai ALM Studio enables you to plan your releases

• Milestones, and planned tasks) • add requirements to your Releases and monitor

the progress of your processes via statistics and graphs.

• An interactive Gantt chart helps you plan and manage your releases and sprints

Test Management

• Test Management is integrated in the ALM functionality and uses Kovair’s Omnibus integration to connect to (nearly any) repository of your choice

• Manage testing easily • Test cases can be generated automatically from whatever action you define. • Test sets combine according to your Test Strategy and Regression Strategy. • Reuse concept is generated according to your plans and Strategies. • A Test Coverage Browser is available to help you ensure the complete test coverage of your

requirements, and to show bidirectional traceability Data Analytics and Reporting • Kovai ALM Studio stores all your production and historical data in its central repository from

requirements through to testing and delivery. You decide if versioned or not. • Data analytics and reporting features help make sense of all that data to unlock valuable insights.

Search and filter data using queries, visualize it using preconfigured charts and diagrams, send automated reports, and

• Analyze data to support decision-making. • Data visualization enables you to monitor process and project KPIs and as well business KPI’s

Thus you can take action before your project “drifts away”. • Dashboards and reports with benchmarks, visualized data, and production insights may be simply

created and shared with others.

Deutscher Mittelstand Ltd. Kovair Distributor for Europe Schillerstrasse 12/1 D-73249 Wernau Phone | +49 7153 750 9918

Kovair Software, Inc. 2410 Camino Ramon, STE 230, San Ramon, CA 94583, USA Phone: +1.408.262.0200