We offer consultation services to medical device companies on medical device quality systems, regulations, compliance, directives and approval. 508-934-6600
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Medical Device Consultant | FDA Medical Device Regulation | AlvaMed | alvamed.com Reviews
https://alvamed.com
We offer consultation services to medical device companies on medical device quality systems, regulations, compliance, directives and approval. 508-934-6600
alvamed.com
QMS Compliance | alvamed.com
http://alvamed.com/services/quality-assurance
Device Registration & Approval. Clinical Affairs Support & Outsourcing. QMS implementation for small high-growth medical device companies. QMS administration and management for small high-growth medical device companies. Audits to QSR 21 CFR Part 820 for medical device companies. Audits to ISO 13485 for medical device companies. QA and RA due diligence audits of medical device companies. Quality assurance regulatory affairs and clinical affairs outsourcing. Design Control Document Templates.
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http://alvamed.com/services/regulatory-affairs-fda
Device Registration & Approval. Clinical Affairs Support & Outsourcing. Medical device regulatory strategy. Medical device reimbursement assessment. Submissions for 510k clearance, PMA and CE Mark. EMDR adverse event reporting. From 483 and Warning letter analysis, response and recovery. Medical device UDI consulting and training. ISO 14971 risk management consulting for medical device companies. On-site group ISO 14971 training for medical device companies. GMP and CE Certification.
Regulatory Affairs Support | alvamed.com
http://alvamed.com/services/due-diligence-n-the-act-of-leaving-no-stone-unturned
Device Registration & Approval. Clinical Affairs Support & Outsourcing. Medical device regulatory strategy. Medical device reimbursement assessment. Submissions for 510k clearance, PMA and CE Mark. EMDR adverse event reporting. From 483 and Warning letter analysis, response and recovery. Medical device UDI consulting and training. ISO 14971 risk management consulting for medical device companies. On-site group ISO 14971 training for medical device companies. GMP and CE Certification.
Regulatory Affairs Support | alvamed.com
http://alvamed.com/services/regulatory-affairs-–-mdd
Device Registration & Approval. Clinical Affairs Support & Outsourcing. Medical device regulatory strategy. Medical device reimbursement assessment. Submissions for 510k clearance, PMA and CE Mark. EMDR adverse event reporting. From 483 and Warning letter analysis, response and recovery. Medical device UDI consulting and training. ISO 14971 risk management consulting for medical device companies. On-site group ISO 14971 training for medical device companies. GMP and CE Certification.
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