Medical Devices

A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent or other similar article which is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions.There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include simple devices like wound dressings and scalpels ; durable devices like wheelchairs and dentist chairs ; implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints, life-supporting devices like respirators and lung ventilators; sophisticated, software-controlled devices like CT scanners and MRI machines.

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Occupational Health safety

OHSAS 18001

Requirement

Requirement for regulatory purposes is an internationally agreed standard that sets out the needs for a quality management system specific to the medical devices industry.It is designed for use of organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation, servicing and the provision of associated services.

Benefits to the organizations

Safety and performance of medical devices are paramount in this highly regulated industry; that is why quality management system is a regulatory or legal requirement in many countries.

  • Demonstrate compliance with regulatory and legal requirements; 
  • Managing risk effectively
  • Improving processes and efficiencies
  • Gaining competitive advantage
Transition to Revised ISO 13485 standard

Safety and performance of medical devices are paramount in this highly regulated industry; that is why quality management system is a regulatory or legal requirement in many countries.

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Management System Standards

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Inspection & Technical Services

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Training & Capacity Building

Organic Certification

It is an accredited process for producers of organic food and other agricultural products. The primary purpose and intention of this certification is to assure quality of product and prevent fraud before sales. That is why demand for this certification is growing day by day globally.

HALAL Certification

Halal is an Arabic term, it is an object or an action which is permissible to use, according to Islamic law. The term covers and designates not only food and drink as permissible according to Islamic law, but also all matters of daily life.


Product Certification

product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.


Careers

Experienced Consultants of sector specific, Auditors, Technical experts and Trainers who wish to serve and share their knowledge for full time or visiting basis are welcome to join us.

Internship Opportunities

Students and fresh engineers of Mechanical, Electrical, Metallurgical, Chemical, Food Technology and Microbiologists, whether you are a recent graduate, working with Smartedge could be a challenging and rewarding next step in their career.

Clients


Technical Services

1)Refractory Management Practices
2)Technical Services- Cold Rolled Steel Manufacturing Services


Inspection Services

Do you need assistance in assuring your product quality as per the agreed specification before your product is being shipped?

Audit Services

Safety Audits, Supplier Audits, Outsource Management System Audits