smartedge logo5

ISO 13485 Certification

iso 13485 certification

ISO 13485 Certification

Introduction to ISO 13485:2016-Medical devices- Quality management systems.

ISO 13485 Certification address the fallowing Industry Challenges and concerns. It should come as no surprise that, success in the medical devices industry means that you need to overcome compliance challenges. The case for quality compliance in the medical devices industry is indisputable – quality affects every stakeholder in the medical value chain. Quality is a fundamental concern at all stages of design, manufacturing, and marketing. 

The cost of quality failure can be exorbitant as seen many times throughout history. Luckily, quality compliance today, though complex, is not as gargantuan of a task as it sounds. to 

What is a medical device?

A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar article, that 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 ; and in vitro diagnostic reagents and test kits.

What is ISO 13485 Certification -Medical Device Quality Management System:

A medical device quality management system (QMS) is a set of policies, processes and procedures that help an organization meet the requirements expected by its stakeholders. It is based on the Plan-Do-Check-Act cycle, a four-step management method used in business for the control and continual improvement of processes and products.

In the medical devices industry, a QMS is required by regulators in most countries. ISO 13485 enables an organization to consistently provide safe and effective medical devices and fulfil customer and regulatory requirements. It is also flexible enough to meet the individual needs of different types of medical devices organizations.

Regulations differ widely from one country to another. For this reason, ISO 13485 does not set detailed requirements, but asks a medical devices organization to identify those regulatory requirements that are relevant to its individual situation and incorporate them into its QMS.

Why to have ISO 13485 Certification

  • Eliminate uncertainty, and widen market opportunities;
  • Increase access to more markets worldwide;
  • Increase efficiency, cut costs and monitor supply chain performance;
  • Produce safer and more effective medical devices meeting regulatory requirements and customer expectations.

What benefits will ISO 13485 Certification bring to organizations ?

  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies as necessary
  • Gain a competitive advantage

Applicable to:

  • Medical Device Manufacturers and organizations involved in one or several stages of a Medical Device Lifecycle like Design and Development, Production, Storage, Distribution, Installation and Servicing.
  •  External providers like Raw materials, Components, Sub-assemblies, Medical devices, Sterilization services, Calibration services, Distribution services and Maintenance services.

Our Consulting approach:

  • Gap Analysis:  Assessment of existing management system practices against the ISO 13485 Certification standard requirements.
  • Project Plan: Prepare ISO 13485 Certification implementation project plan based on the time lines looking for; 
  • Orientation Training:  Top/Senior Management orientation on selected standard requirements and ISO 13485 Certification implementation action plans preparation;
  • Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;       
  • System Implementation: Implementation of the selected management system as per the developed documentation;
  • Company-wide Training: Training on detailed clause wise requirements and relating them to their departments and Internal audit.
  • Internal Audits: Periodic assessment of system implementation and corrective actions.
  • Pre assessment:  Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification.
Open chat
available for chat