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By Industry
Medical Device
New Product Approval
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Compliance Audits
MDSAP
Data Integrity & GMP Consulting
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ISO 13485
Clinical Evaluation Report (CER)
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Import & Export Support
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By Industry
Medical Device
New Product Approval
Compliance Assessment
Regulatory Gap Analysis
510(k) Submission
Compliance Audits
MDSAP
Data Integrity & GMP Consulting
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ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
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Post Approval Support
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July 22, 2022
Elexes Team
Time to revisit your Medical Device’s classification in Australia (TGA): Reclassification Update in Brief
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July 22, 2022
Elexes Team
How can a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer?
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January 12, 2022
Elexes Team
ISO 10993-12:2021
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January 12, 2022
Elexes Team
New Classification list for Medical Device
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Elexes Team
Clinical Evaluation Report (CER)
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June 22, 2021
Elexes Team
Modernization of 510(k) – A major milestone to safer and better healthcare
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