Internal Audit

We provide expertise in auditing that can drive change and improvements more effectively.

Canada Medical Device Registration

How to Get The CMDCAS Approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.

Europe Medical Device Registration

Compliance with CE marking requirements, MDR (Medical Device Regulation 2017/745).

How to Get The FDA Clearance?

In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.

Life Cycle Training
Software Development Life Cycle Training

What will you learn during this Software Development Life Cycle training class.

Risk Management
Risk Management ISO 14971

Risk management according to ISO 14971: training, gap analysis, implementation

ISO 9001 And Main Changes Since 2015

ISO 9001 – Quality management systems requirements, has been updated to revision 2015. The following changes have occurred.

ISO 13485
ISO 13485

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development.

Clinical Evaluation
Clinical Evaluation

Compliance with MEDDEV 2.7.1 and MDR requirements for clinical evaluation. Preparation of clinical evaluation reports, literature search, appraisal.

Biological Evaluation Preparation
Biological Evaluation

Compliance with ISO 10993 requirements, toxicological and biological safety evaluation, biological evaluation report, biocompatibility.

Medical Device Single Audit Program (MDSAP)

MDSAP program compliance preparation, quality system upgrade, maintenance of the system, mock audits.

WHO prequalification
WHO prequalification

Preparation for the WHO prequalification of diagnotics, gap assessment, mock audit, full assistance for the whole process