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IdentityCDAQi one of the leading Global regulatory & Compliance consultants in healthcare domains and also providing Shingo Japanese Management techniques 5S, TQM, TPM, Poke Yoke, Lean Management.
Our team has 16 years of rich industry experience which spans across established standards/regulations for class 1 & 2 medical equipment’s - MDD, ISO 13485, 21CFR820,GMP,Design Controls, CE,FDA 510k approval,62304, 60601-1,60601- 2,62366,60601-1-6,60601-1-8 & ISO 14971, HIPPA Compliance.
OUR KEY OFFERINGS:
Establish a risk management framework Demonstrate compliance to 62304 Establishing 60601-1 and 1-2 practices • Preparation/Review of technical file for CE, 510k file for FDA Audit for QMS and QSR • CAPA Management Quality/Regulatory Documentation • Risk Evaluation Techniques – FMEA & FTA
Quality manual, Procedure Manual, Standard operating procedures) as stipulated in QSR (21 CFR 820)/ISO 13485:2003 /ISO 9001:2008,93/42/EEC, & Relevant standards.
supplier audit
UNFPA qualification audit
LNE-G/Med International audit
USFDA Audit without any FDA 483 observations CE Mark(EC Certificate) Canadian Regulation * Relevant Standards GMP/cGMP compliance snd SOPS
Looking forward to join with you and help our clients to implement International quality & regulatory practices to produce high quality products right at the first time.
