Quality Management Systems and Regulatory Affairs - Helping your business

Article Index



We will assist you throughout the process, while making the system simple: Say what you do, do what you say, prove that you do what you say. We understand your needs and adjust the process of certification to your needs:

• Conduct gap analysis to ascertain present position.

• Plan for establishment and implementation of relevant systems.

• Set up simple policy statement and objectives.

• Train the workforce and Internal Auditors.

• Develop documentation structure.

• Assist Internal Auditors conduct internal audits.

• Assist with selection of Registrar.

• Assist to maintain the system on regular basis.

• Plan for quality.

o Sample plans.

o Statistical techniques.

o Inspections.

o Calibration.

o Selection of instruments.

o Selection of personnel.

Improving efficiencies

• Strategic business planning with analysis of strengths and weaknesses.

• Developing short and long term business goals.

• Developing business plans.

• Introducing lean manufacturing concepts in processes.

• Developing job descriptions & hiring the right personnel.

• Developing performance-based evaluation of work force.

• Enabling management to synchronize energy of the organization behind a shared vision.

• Building strategic management capacity.

• Developing a better understanding of the business environment with analysis of threats and opportunities.

• Developing an alignment between the plan and the team.


Training is an integral part of developing workforce to meet new challenges and it is necessary to determine the

needs for training and to provide the staff the necessary tools to implement continuous improvement strategies. In close cooperation with the management, we provide training in the following aspects:

• Understanding management systems.

• Documentation and quality records development.

• Internal auditing techniques.

• Statistical techniques.

• Improving communication.

Regulatory affairs

We assist the Medical Device companies in Canada in meeting FDA requirements and preparing technical files for

Health Canada, European Union and other countries in regulatory submissions and staff training.

Regulatory submissions

• US FDA 510(k).


• Health Canada (Medical Device Licence).

• Health Canada (Establishment Licence).

• Medical device supplier & internal audits.

• Establishment registration & licensing.

• Registration to industry standards.

• Due diligence.

On & off-site training for employees & supervisors

• Regulatory Processes

• Document Control

• Internal Audits

Business consulting

Preparing an effective business plan is a foundation for a reliable business start and development. We will discuss your specific needs and present an achievable plan to become a partner in your success by reducing unnecessary waste of resources and creating synergies in your processes and personnel. In case you want to know more, please do not hesitate to contact us for initial discussion.