Services & Capabilities

QUALITY ASSURANCE & REGULATORY AFFAIRS


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QUALITY ASSURANCE & REGULATORY AFFAIRS


Promepla OEM Solutions is certified ISO9001 and ISO13485.

Our independant Quality department has developped a documented quality system that allows us to control every process of design, production and quality control.

We can deliver products CE marked and/or in compliance with FDA requirements and /or under Canadian License.

Depending on the product, target market, and requirements profile, we can help bring your product to market. Our regulatory experts on staff monitor the constantly changing national and international regulatory environments.

We can provide expertise in the overall planning and execution of regulatory compliance through all phases of the product life cycle.

Promepla OEM Solution portfolio of services includes:

 

Regulatory Affairs / International Registrations :

  • Regulatory Strategy.
  • EU technical file for CE marking approval.
  • STED – Summary Technical Document Preparation
  • Canada medical device license approval and registration
  • Brasil ANVISA Registrations.
  • International device approvals, licensing, and registration
  • Technical and regulatory information
  • Post Market Surveillance

QMS Compliance :

  • Product master files
  • Creation of QMS in compliance with ISO13485 / 21CFR part 820
  • Design control including design verification and design validation
  • Risk Management according to ISO14971
  • Blank audits
  • Declarations of Conformance to Standards
  • Safety sheets or certificates of analysis
  • Documentation for labeling and promotion claim

Biological / Stability Study :

  • Biocompatibility Study
  • Sterilization Validation: ETO, Gamma Radiation, Beta Radiation, Steam
  • Bioburden Study
  • Sterility and residues control
  • Shelf life validation

Electromedical Devices :

  • Basic safety and essential performance Study.
  • Electromagnetic compatibility study.
  • Software validation.
  • Usability Study.

ISO9001

ISO13485

See all of our certificates


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