{"id":291,"date":"2019-12-18T10:16:43","date_gmt":"2019-12-18T09:16:43","guid":{"rendered":"https:\/\/qcmed.de\/?page_id=291"},"modified":"2025-09-09T15:48:24","modified_gmt":"2025-09-09T13:48:24","slug":"home","status":"publish","type":"page","link":"https:\/\/qcmed.de\/en\/","title":{"rendered":"HOME"},"content":{"rendered":"

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OUR PLUS FOR YOU<\/span><\/p>\n

Our PLUS FOR YOU<\/strong> is our love of our work and the passion that goes into it.<\/span><\/div>\n
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Our PLUS FOR YOU<\/strong> is also your satisfaction–
\nduring the planning, implementation and training with you and your team.<\/span><\/p>\n

The unique integrated approach of qcmed combines the goal of product approval with the successful development of your quality management system.<\/span><\/p>\n

Strategic planning and practical implementation are combined in a consistent concept from which both employees and management will benefit.<\/span><\/p>\n<\/div>\n<\/section>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

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We reliably guide medical device manufacturers, operators and users through the necessary requirements for medical device regulation.<\/p>\n

We quickly and safely bring medical devices to regulatory approval, allowing you to focus on your business.<\/p>\n<\/div>

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OUR SERVICES ARE AS VERSATILE AS YOUR REQUIREMENTS.<\/span><\/h1>\n<\/div>
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We serve medical device manufacturers, operators and users.<\/p>\n

As a qualified and competent partner, we advise companies in Germany and throughout the world.<\/p>\n

> <\/span>Founders and developers
\n> <\/span>Established companies
\n> <\/span>Private institutions and health care organizations<\/p>\n<\/div>

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We implement and improve quality management systems according to:<\/span><\/p>\n

> ISO 9001<\/span>
\n> EN ISO 13485<\/span>
\n> ISO 15378 (GMP & ISO 9001)<\/span>
\n> US-QMSR (21CFR 820) cGMP<\/span>
\n> MDSAP<\/span><\/p>\n<\/div>

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<\/i><\/i><\/span>REGULATORY APPROVAL<\/span><\/a><\/h4><\/div>
The international regulation of the medical devices market demands an international approval strategy. Qcmed supports you in creating a tailored concept.<\/p>\nCE Marking<\/mark>
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MDR 2017\/745 EU Medical Device Regulation
\nActive Implants (90\/385\/EEC)
\nMedical Devices (93\/42\/EEC)
\nIn-vitro diagnostics (98\/79\/EC)<\/p>\n

><\/span> Product classification
\n><\/span> Selection of the conformity assessment procedure
\n><\/span> Technical documentation
\n><\/span> Selection of notified body
\n><\/span> Implementation and coordination of regulatory approvals
\n><\/span> National registration<\/p>\nRisk Management<\/mark>\n

><\/span> Risk analysis and management
\n> <\/span>EN ISO 14971, EN ISO 22442, IEC 80001-1
\n> <\/span>Risk management file
\n> <\/span>Post-marketing surveillance
\n> <\/span>Monitoring and reporting system
\n> <\/span>(MEDDEV, MPSV, MDR)<\/p>\nUSA: Your way to FDA<\/mark>\n

> <\/span>Classification
\n><\/span> Documentation (DMR)
\n> <\/span>510(k), IDE, PMA
\n> <\/span>Establishment Registration
\n> <\/span>International device listing
\n> <\/span>Other countries upon request (e.g. Canada, Australia)<\/p>\nTechnical Documentation<\/mark>\n

DMR, DHF<\/p>\n

> <\/span>Conforming to standards, ready for submission
\n> <\/span>In accordance with your Notified Body
\n> <\/span>Instructions for use, labelling
\n> <\/span>International strategy<\/div><\/div><\/div>

<\/i><\/i><\/span>QUALITY MANAGEMENT<\/span><\/a><\/h4><\/div>
A QM System should not only meet regulatory requirements. A good QMS should be a valuable management tool, with which you can optimally exploit your company’s potential for improvement. This saves time and money.<\/p>\nOur Service<\/mark>\n

><\/span> Selection of Notified Body
\n><\/span> Setup, maintenance and review of your QM System
\n><\/span> QM Manual, SOPs and work instructions
\n><\/span> Process analysis, visualization and optimization
\n><\/span> Risk management and CAPA
\n><\/span> Audits and system analysis\u2014internal and for suppliers<\/p>\nProduction\/Hygiene<\/mark>\n

><\/span> Hygiene requirements
\n><\/span> Production in cleanrooms
\n><\/span> Validation of sterilization processes
\n><\/span> Management of test equipment
\n><\/span> Process validation
\n><\/span> Refurbishing of medical devices
\n><\/span> Package validation<\/p>\nWe implement and improve Quality Management Systems according to: <\/mark>\n

><\/span> ISO 9001
\n><\/span> EN ISO 13485
\n><\/span> ISO 15378 (GMP & ISO 9001)
\n><\/span> US-QSR (21CFR 820) cGMP
\n><\/span> MDSAP<\/div><\/div><\/div>

<\/i><\/i><\/span>TESTING<\/span><\/a><\/h4><\/div>
Your product is in good hands.<\/p>\n

One stop shopping. Together with our trusted partners, we organize and offer comprehensive testing.<\/p>\nSoftware validation<\/mark>
\n<\/b><\/p>\nPlanning of valid test programs<\/mark>
\n<\/b><\/p>\nConsulting and testing strategy for \u2026<\/mark>
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><\/span> Biocompatibility (ISO 10993, USP)
\n> <\/span>Electrical safety, EMC
\n><\/span> Usability
\n> <\/span>Test for implants ISO 5840, ISO 7198
\n> <\/span>Extractables<\/div><\/div><\/div>

<\/i><\/i><\/span>SEMINARS and Workshops<\/span><\/a><\/h4><\/div>
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Improve your competency with our tailored training. Broaden your knowledge via individual seminars and workshops.<\/p>\nOur service<\/mark>\n

> <\/span>Up-to-date information about medical devices and quality management
> <\/span>By far the best: seminars at qcmed
> <\/span>Practical: seminars in your office
> <\/span>Learn in small groups<\/p>\n

We are looking forward to your inquiry.
info@qcmed.de<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>

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DIN EN ISO 9001 certified<\/span><\/a><\/p>\n<\/div>

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