Regulatory & Quality

Compliance solutions for Medical Device companies.

Strafom offers technical consultancy support to QMS solution, regulatory advisory & guidance, Risk management support, assists in Clinical Trials, Clinical investigations and evaluation support to various manufacturers in the healthcare industry to ensure their products, processes, systems or services are compliant with national and international regulations and standards.

We will help in getting approval to various standards.

Functional Areas

QMS

Typically, we recommend implementing a new ISO 13485 quality system plan over a period of 6 months. The reason for this is that people can only read procedures and complete training at a certain pace.

Regulatory

On April 5, 2017 the EU adopted the new Medical Devices Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation will enter into force after a three-year transition period ending in spring 2020.

Compliance

Product compliance – or product conformity – is certainty that a product meets the regulatory requirements necessary to be available on the market.Companies bringing products on to the market fall under legal obligation to take the actions necessary to ensure product compliance.

Training

Training is teaching, or developing in oneself or others, any skills and knowledge that relate to specific useful competencies. Training has specific goals of improving one’s capability, capacity, productivity and performance. In Meditix we are focusing on conducting Regulatory, QMS and Clinical Trainings as per the Client’s requirement.