Regulatory And Qa

Medical Device Regulatory Services

We offer strategic guidance to our clients at every stage of the product development process. Our regulatory experts have extensive experience in multiple regulatory jurisdictions, including MDSAP (Australia, Brazil, Canada, Japan, United States), EU MDR and mor

Go-To-Market Assistance

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Medical Device Regulatory Services

We offer strategic guidance to our clients at every stage of the product development process. Our regulatory experts have extensive experience in multiple regulatory jurisdictions, including MDSAP (Australia, Brazil, Canada, Japan, United States), EU MDR and mor

Go-To-Market Assistance

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Regulatory Support :

We offer end-to-end guidance to help you take your product to market. At every stage of your project we assist you in meeting regulatory requirements.

Quality Control

We perform quality control at every stage of the product lifecycle :

  • CAPA management
  • Gage R&R analysis
  • Statistical process control (SPC)
  • Design control
  • Lean Six Sigma protocol
  • Regular supplier audits & gap analysis
  • Process validation


Risk Management

We identify, analyze, and mitigate risks associated with Class I and Class II medical devices. We ensure:

  • ISO 14971:2019 implementation
  • FMEA
  • Health Hazard Evaluation
  • Supplier authorisation and qualification over parameters of quality,timeline and efficiency


Risk Management

We identify, analyze, and mitigate risks associated with Class I and Class II medical devices. We ensure:

  • ISO 14971:2019 implementation
  • FMEA
  • Health Hazard Evaluation
  • Supplier authorisation and qualification over parameters of quality, timeline and efficiency


# 136/7,Durga Bhavan Bible House Main Road,Rashtrapati Road,Beside Laxmi Vilas Bank,Rani Gunj,Secunderabad, Telangana, 500003

7569973672

Customer Care Number

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