Medical Device Consulting Services

Medical Device Consulting Services.

Wee what kind of services we propose below:

Internal Audit

Internal and supplier audits as part of our medical device consulting services

Canada Medical Device Registration

How to Get 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).

FDA clearance
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

How to achieve compliance with IEC 62304 ? We describe the approach and the service we provide

Risk Management
Risk Management ISO 14971

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

Medical Device Consulting Services
ISO 9001 And Main Changes Since 2015

ISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities.

Medical Device Consulting
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

The medical device consulting services above are performed by professional experts having the required experience and certification to perform such activities. Medical devices are regulated in most countries. Pre-market and post-market requirements apply in most cases. For instance in Europe the European Commission publishes here information about how medical devices are regulated in the European Union. We only deal with medical devices and in vitro diagnostic devices. We do not provide service for other products such as medicine, cosmetics or food.

Medical Devices

Medical Device Consulting Services