Consultancy Services

I)Assistance in Regulatory Services:

i) System implementation assistance as per QSR 21 CFR Part 820 requirements
ii) System implementation assistance as per ISO 13485:2003/EN ISO 13485:2012 requirements
iii)510K submission/ Assistance for Pre Market approval(PMA)
iv) Technical File submission as per 93/42/EEC requirements for CE Marking
v) Computer System Validation(USFDA 21 CFR Part 11)
vi) Risk Management Process as per ISO 14971:2007/EN ISO 14971:2012

II) Organizational Transformation Services

i)5S(Workplace excellence)
ii)TPM(Total Productive Maintenance) implementation
iii)TQM(Total Quality Management) implementation
iv)TEI(Total Employee Involvement) implementation
V) POKA YOKE(Mistake Proofing)
VI) KRA(Key Result Area
VII) Lean, Kaizen, Balance Score Card