Wir freuen uns, dass sie auf unserer Internetseite sind und möchten uns über diese Seiten vorstellen.
Möglichweise kennen sie uns noch gar nicht, haben eine spezifische Frage und suchen nach Antworten.
Oder Sie / Ihr Team müssen eine Aufgaben / Projekt zeitnah bearbeiten, haben jedoch nicht die erforderlichen Ressourcen zur Verfügung oder wissen nicht so richtig wie es «anzupacken» ist.
Und genau das ist das Credo von bleyco swiss GmbH: Hands-on!
Wer ist bleyco swiss GmbH?
Wer ist bleyco swiss GmbH?
Dienstleistungen
Wer ist bleyco swiss GmbH?
TOP Thema: Händler unter MDR & IVDR
TOP Thema: Händler unter MDR & IVDR
TOP Thema: Händler unter MDR & IVDR
Der dritte Schritt
Privacy Policy
MedTech - Pharma - Cosmetic
Our strength is your benefit
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Our approach: Do it right first!
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We understand hands-on as the consistent application of effectiveness
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Because you as a customer must be able to derive maximum benefit from our services.
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With a sense of proportion, according to your needs and compliant with the requirements
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It is crucial to grasp the critical dependencies (critical path) quickly , but not to lose yourself in detail.
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Micro management mostly just absorbs resources.
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Because a little more blur brings more efficiency!
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By the way: "Being creative" is not synonymous with "being unstructured".
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Ensure compliance to ISO 11607
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Creating the entire packaging system documentation
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Managing Packaging System Performance testing
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Managing Sterile Barrier System Stability testing
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Packaging System risk assessement according to ISO 14971
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Creating SOPs and Rationales
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Development of forms and templates
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Be ready for audits & inspection
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With a smart assessment tool we can investigate gaps in relation to:
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ISO 13485
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21 CFR 820
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GMP
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and ISO 9001 (maybe your supplier does not hold an ISO 13485 but an ISO 9001 certificate)
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Supporting the TD packaging part to receive the MDR certificate
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Sharing best practise
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Address questions originally asked from the Notified Body
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Intellectual property is their capital.
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Please do not underestimate this factor, especially because it has a tax-reducing effect, in Switzerland.
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We work together with proven experts who, can apply the method of providing evidence (Note: The tax authority in Switzerland would like to see it)
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And our expert writes and registers your patent (claim) on paper.
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Providing guidance to comply with the new regulatory requirements
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Set up Risk Management Process in conjunction with Usability testing
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Sampling plan based upon statistically valid rationale
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Smart selection of climate testing conditions
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Rationale to select appropriate performance test conditions
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Set up a smart process validation, e.g. platform approach
Temporary work or work on contract
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bleyco swiss GmbH holds a licences for the professional hiring of services in the form of temporary work or work on contract within Switzerland.