ISO 13485
| Our Servises | |||
| Consulting for implementation of ISO 13485 requirements | Training, skill & competence development | Internal audit of ISO 13485 requirements | Supply chain development to enable ISO 13485 compliance |
ISO 13485 Quality Management System - Medical devices
1SO 13485:2016
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
Critical changes from ISO 13485:2003:
- The 2003 version based on ISO 9001:2000; 2016 based on ISO 9001:2008
- The Standard is brought into alignment with the nonconformance grading systems of the MDSAP program
- The ideas and concepts in the Standard are somewhat generic, which are made specific by the regulations in a given region
- Can exclude any requirements in clauses 6 (resource management), 7 (Product realization) or 8 (measurement, analysis and improvement) if justifiable
- Expected to apply Risk-based Approach (Risk-based Thinking) to all QMS processes
- Must comply with all applicable regulatory requirements (statutory, legal) pertaining to applicable regions
- Medical device file must include a description of each medical device or family of devices, and include all associated specs., procedures & records
- Expected to evaluate record and monitor suppliers. Need to consider risk to the medical device whenever suppliers underperform.
- Expected to think about safety and performance of products and the associated training needs of users and to verify that regulatory requirements will be met and user training will be available before supplying products to customers.
- Need to consider the risk to the medical device in addition to the effect purchased product has on the safety and performance of the medical device.
- Need to make sure that suppliers are capable of meeting all relevant statutory requirements in addition to organization’s requirements.
- Need to consider the risk associated with the product purchased and consider what action to take when unanticipated changes are made to purchased products and to determine whether these changes affect the medical device or product realization process.
- The 2016 version is in much better alignment with the U.S. QSR Vs. the 2003 version.
- Any medical device marketed in the U.S. must be in line with the QSR, regardless of where its bee designed and manufactured.
- ISO 13485:2016 is not legally sufficient to meet the U.S. requirements.
Click on these links below to know more
- INFORMATIVE REFERENCES AND GUIDANCE STANDARDS FOR ISO 13485
- EN ISO 14971:2012 provides a process for managing risks associated with medical devices. Because this standard describes an ongoing, lifecycle process applicable in part or in all to the essential requirements of Directive 93/42/EEC on Medical Devices. Compliance with all the normative clauses in EN ISO 14971 will ensure that a process is in place to address general risk management aspects related to medical devices, which are included in the essential requirements.
- Those or other stakeholders to hazards which can cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity.
- The risk management process includes the following elements:
- Risk analysis
- Determination of intended use and identification of safety characteristics relating to the medical device
- Hazard identification
- Estimation of risk(s) relating to the hazards
- Risk evaluation
- Criteria to be defined by the medical device manufacturer, for each hazardous situation identified, whether risk reduction is required or not.
- Risk control
- Analysis of risk control options
- Implementation of risk control measures
- Evaluation of residual risk
- Risk / Benefit analysis
- Risks arising from risk control measures
- Completeness of risk control
- Production and post-production information
- A– Establishing, documenting and maintaining a system of reviewing information pertaining to production and post production phases of a medical device or any similar devices.
- Risk analysis
- ISO 10993 -1-22 SERIES – BIOCOMPATIBILITY EVALUATION OF MEDICAL DEVICES
- The ISO 10993 series refers to standards associated with biocompatibility of medical devices. Biocompatibility in this context refers to the behaviour, performance and interactions of medical devices with an appropriate host tissue response in a specific situation. Biocompatibility evaluation deals with biological effects of a medical device on the human body at a cellular, tissue and organ level.
- The biological effects include
- Cytotoxicity - Toxic to cells
- Sensitization – Allergic response to acute and prolonged exposure to medical devices
- Reactivity – Adverse effects of medical devices
- Systemic toxicity – Toxicity caused by effects caused by absorption, distribution and metabolism of substances emanating from medical devices.
- Pyrogenicity – Ability to induce a febrile response as a result of presence of microbial or material pyrogens in a medical device
- Subacute/Subchronic toxicity - effects a material with repeat exposure would have on host body
- Genotoxicity – Effect towards the genetic material on exposure to a medical device. This includes mutations, DNA double strand breaks and apoptosis.
- Implantation – localized effects as a result of implantation of medical devices
- Hemocompatibility – Evaluation on interaction of medical devices on blood and blood components. This is with regards to five categories:
- Thrombosis
- Coagulation
- Platelets
- Hematology
- Complement System
- Chronic toxicity – Toxicity over a prolonged period of time
- Carcinogenicity - Ability of a medical devices to potentially induce tumor/neoplastic transformations in host cells
- Reproductive/developmental toxicity – Toxic effect of material in medical devices towards reproductive function (spermatogenesis/oogenesis), embryonic morphology (teratogenic), prenatal and post-natal development.
- Degradation – Toxic Effect of products resulting from breakdown of materials in medical devices over a period of time.
Search site
E-Qual receives appreciation from TI Group
-------------------------------------------------
E-Qual receives appreciation from Mahindra & Mahindra
for knowledge support in implementing Energy Management System to ISO 50001: 2018
-------------------------------------------------
"We are extremely delighted to have your consultancy for the successful completion of the process
Thank You for all your support and guidance"
Regards,
MRV Infra Management
E-Qual receives appreciation from Salcomp
We are extremely appreciative of the efforts of Management Consultants E-Qual.
As implementing partner of Assist, they developed skills, 20 QEHS Champions (Quality, Environmental, Health and Safety ) in our supply chain and bringingout an excellent QEHS implementation handbook for continued guidance in their day to day implimentation
Managing Director
Log-in : "My E-Qual" Gateway