Strategic Regulatory Planning
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Developing a regulatory strategy depending on the product and desired market, including classification of device
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Selecting the appropriate Notified Body for your product
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Gap-Analysis – identifying and reviewing gaps in regulatory compliance
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Periodic Standards Review
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MDR 2017/745 readiness assessment and transition strategy
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Regulatory Due Diligence for projects and prospective acquisitions
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Full registration in global markets, including set-up of technical documentation:
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Europe – CE Marking – Technical Files (Class II) & Design Dossiers (Class III):
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MDD 93/42/EEC amended by 2007/47/EC
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AIMDD 90/385/EEC
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MEDDEV 2.7/1 rev. 4 – Clinical Evaluation Report (CER)
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Biocompatibility Risk Assessment – EN ISO 10993-1:2018
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Developing and implementing Risk Management programs – EN ISO 14971:2012
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Design Control – DHF
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Verification & Validation activities & evaluations
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IQ/OQ/PQ
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PMS activities (including Vigilance – reviewing & reporting incidents, field actions and adverse events)
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PMCF – MEDDEV 2.12/1 rev. 8
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MDR 2017/745 Gap-Analysis
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USA – FDA:
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FDA 510(k) submissions & pre-submissions for implants
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MAF submission for new biomaterials
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eCopy preparation
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Canada – Health Canada MDL & MDEL submissions
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China – CFDA Regulations submissions for Class II & Class III medical devices
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Israel – AMAR Registration
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Brazil – ANVISA Registration
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Argentina – ANMAT Registration
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Colombia – INVIMA Registration
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South Africa – SAPHRA Registration
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