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ISO Standards for Medical Devices: ISO 13485:2016, ISO 10993-1 and MDSAP

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QSE: 27+ Years of Experience in Training, Consulting, & Auditing

Summary of Services:

Medical Device Definition:

“Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act is regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and post-marketing regulatory controls.

A device is:

  • An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    3. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

  (Source: https://www.fda.gov/medical-devices/classify-your-medical-device/product-medical-device)

Every Medical device used in USA whether produced in USA or Not  must be certified as per guidelines provided by FDA in 21 CFR 820 which have been adapted by ISO Standards for medical devices as ISO 13485. The Latest in this being ISO 13485:2016. This standard follows Quality Management Systems prescribed in ISO 9001:2008.

QSE promotes the other popular standards connected to ISO Standards for Medical Devices such as Medical devices — Quality management systems — Requirements for regulatory purposes 13485:2016, Medical Devices Single Audit Plan (MDSAP), Biological Evaluation of Medical Devices ISO 10993-1.

For effective implementation for ISO 13485 standard,  the organizations develop ISO 13485 audit checklists to conduct ISO 13485 Gap analysis, develop ISO 13485 training materials to disseminate to all interested parties related to ISO 13485 requirements, develop ISO 13485 Quality Management System, conduct ISO 13485 internal audits, using ISO 13485 audit checklists and conduct management review of the ISO 13485 Quality Management System for ISO 13485 standard compliance  prior to ISO 13485 certification audit.  Any organization seeking ISO 13485 certification may use ISO 13485 Consulting, ISO 13485 Auditing and ISO 13485 Training entities. A competent ISO 13485 consultant may be present during ISO 13485 certification audit to defend the established ISO 13485 Quality Management System without interfering with ISO 13485 certification auditors.

For effective implementation for ISO 10993 standard,  the organizations develop ISO 10993 audit checklists to conduct ISO 10993 Gap analysis, develop ISO 10993 training materials to disseminate to all interested parties related to ISO 10993 requirements, develop ISO 10993 Quality Management System, conduct ISO 10993 internal audits, using ISO 10993 audit checklists and conduct management review of the ISO 10993 Quality Management System for ISO 10993 standard compliance  prior to ISO 10993 certification audit.  Any organization seeking ISO 10993 certification may use ISO 10993 Consulting, ISO 10993 Auditing and ISO 10993 Training entities. A competent ISO 10993 consultant may be present during ISO 10993 certification audit to defend the established ISO 10993 Quality Management System without interfering with ISO 10993 certification auditors.

For effective implementation for MDSAP standard, the organizations develop MDSAP audit checklists to conduct MDSAP Gap analysis, develop MDSAP training materials to disseminate to all interested parties related to MDSAP requirements, develop MDSAP Quality Management System, conduct MDSAP internal audits, using MDSAP audit checklists and conduct management review of the MDSAP Quality Management System for ISO 13485 standard compliance prior to MDSAP certification audit.  Any organization seeking MDSAP certification may use MDSAP Consulting, MDSAP Auditing and MDSAP Training entities. A competent MDSAP consultant may be present during MDSAP certification audit to defend the established MDSAP Quality Management System without interfering with MDSAP certification auditors.

Quality Systems Enhancement (QSE) is a premier ISO Consulting, Auditing and Training firm engaged in assisting facilities obtain their certification to any standard. QSE has been founded in 1992 and since then there are more than 700 companies that have sought assistance from QSE and obtained their ISO certifications.

QSE was promoted and is managed by Mr. Baskar Kotte who has over 40 Years’ experience in offering business solutions, quality assurance, ISO consulting, auditing and training now. QSE has a team of qualified and competent consultants to assist businesses and help them achieve ISO certifications and other certifications

QSE has helped several organizations in obtaining ISO 13485 certification Nexxspan Health services is one among them from Atlanta, GA and others spread across length and breadth of USA.

QSE Offers ISO 13485 Consulting, ISO 13485 Internal Auditing and ISO 13485 Training. QSE also provides ISO 10993-1 certification assistance through ISO 10993-1 Consulting, ISO 10993-1 Auditing and ISO 10993-1Training in Biological evaluation of Medical devices; QSE’s (MDSAP) Medical Device Single Audit Plan covers requirements for quality and competence of MDSAP Auditing, MDSAP Consulting and MDSAP Training.

QSE is careful about following relevant Quality management standards along with selected medical device standard. For Example, ISO 13485 :2016 follows the QMS based on ISO 9001:2008 where as others follow ISO 9001:2015.

QSE is relevant to these standards since QSE has a track record of 100% success in obtaining certification to any standard. 98% of them get through certification without any nonconformities first time around.

Who should get ISO 13485:2016 Certification

  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products for any facility is necessary to assure their customers that the facility can produce products or services with consistent quality
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification ISO Standards for Medical Devices and related products is helpful in streamlining all the processes in to a single management system
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products brings in continual improvement in any organization
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products elevates any facility to be a global level company
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification ISO Standards for Medical Devices and related products is required as a good marketing tool
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification for ISO Standards for Medical Devices and related products is required to reap many benefits like process control, monitoring and measurement of process outputs, control of products and services from external providers
  • ISO 13485 Standard or ISO 10993-1 standard or MDSAP standard for ISO Standards for Medical Devices and related products pave the way for building quality for any product or service by utilizing relevant standard
  • ISO 13485 Standard or ISO 10993-1 standard or MDSAP standard for ISO Standards for Medical Devices and related products, require disciplined management systems that is an effective monitoring tool for all operations within the facility
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification for ISO Standards for ISO Standards for Medical Devices and related products is required for global acceptance of all goods or services from a facility
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification encompasses all activities under each facility considers all issues and concerns of all interested parties
  • ISO 13485 compliance or ISO 10993-1 compliance or MDSAP compliance for ISO Standards for Medical Devices and related products avoids or minimizes FDA audits

ISO 13485

  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products for any facility is necessary to assure their customers that the facility can produce products or services with consistent quality
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification ISO Standards for Medical Devices and related products is helpful in streamlining all the processes in to a single management system
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products brings in continual improvement in any organization
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification in ISO Standards for Medical Devices and related products elevates any facility to be a global level company
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification ISO Standards for Medical Devices and related products is required as a good marketing tool
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification for ISO Standards for Medical Devices and related products is required to reap many benefits like process control, monitoring and measurement of process outputs, control of products and services from external providers
  • ISO 13485 Standard or ISO 10993-1 standard or MDSAP standard for ISO Standards for Medical Devices and related products pave the way for building quality for any product or service by utilizing relevant standard
  • ISO 13485 Standard or ISO 10993-1 standard or MDSAP standard for ISO Standards for Medical Devices and related products, require disciplined management systems that is an effective monitoring tool for all operations within the facility
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification for ISO Standards for Medical Devices and related products is required for global acceptance of all goods or services from a facility
  • ISO 13485 certification or ISO 10993-1 certification or MDSAP certification encompasses all activities under each facility considers all issues and concerns of all interested parties
  • ISO 13485 compliance or ISO 10993-1 compliance or MDSAP compliance for ISO Standards for Medical Devices and related products avoids or minimizes FDA audits

Tools and Techniques, We Bring in for ISO 13485 Certification or ISO 10993-1 Certification or MDSAP Certification

  • QSE’s documentation for Medical Devices and related products is a unique, comprehensive, single level and simplified
  • QSE’s documentation is lean, easy to adapt and implement
  • QSE provides ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting through use of ISO 13485 templates, ISO 10993-1 templates and MDSAP templates which are tried and tested. No nonconformity crops up during any audit if all templates and documents are strictly followed
  • QSE provides ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting that ensures comprehensive, simplified, single level documentation system for ISO 13485 certification or ISO 10993-1 certification or MDSAP certification with a complete quality management system which covers all elements of the standards clause by clause
  • QSE provides ISO 13485 training ISO 10993-1training and MDSAP training that is an excellent measure to implement required system using ISO 13485 templates, ISO 10993-1 templates and MDSAP templates
  • QSE provides ISO 13485 auditing ISO 10993-1auditing and MDSAP auditing using ISO 13485 audit checklists, ISO 10993-1 Audit checklists and MDSAP Audit checklists for through audits which are more stringent than 13485 certification audits or ISO 10993-1 certification audits or MDSAP certification audits
  • QSE provides indisputably excellent training by a certified quality engineer and an exemplar global certified lead auditor with over 40 years of experience. Several testimonials stand witness to this fact
  • QSE has been involved in writing guidance standards ISO19011 from its inception till recent revisions in 2018 for auditing and hence thoroughly understands the requirements for ISO 13485 audit ISO 10993-1audit and MDSAP audit
  • QSE provides excellent tools and techniques during training of internal auditors for ISO 13485 audit ISO 10993-1audit and MDSAP audit QSE includes unique humanistic elements during an audit or training an auditor
  • QSE prepares all documentation at customer’s site in consultation with all relevant employees and management
  • QSE ensures that certification is obtained within minimal time and as cost effective as possible
  • QSE assists in choosing Certification Bodies at no extra cost to customer. Because of QSE’s effective negotiations, and expert knowledge of IAF MD 5:2009, QSE can help Customer  save about 20% on registration costs. 

Outcomes of Our Consulting Service

  • First major outcome of the consulting is a complete fully developed Management system which satisfies all element of the standard chosen
  • Competent employees fully trained to effectively implement established system
  • QSE during ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting for Medical Devices and related products provides unique templates to gather internal and external issues that may affect the management System, QSE also provides templates to depict the process flow and interactions for all processes
  • QSE develops nearly 30 Documented processes required for Medical Devices and related products certification to ISO 13485:2016 and any requirements for other standards
  • QSE provides adequate training for ISO 13485 standard, ISO 10993-1 standard, and MDSAP standard, to top management for demonstrating leadership on commitment, involvement and engagement for manufacture of Medical Devices and related products
  • QSE facilitates top Management for clear strategic direction which is aligned with Quality Policy, Quality Objectives, and change planning/control
  • ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting by QSE enables Top management to have coaching’ top management to effectively promote Risk Based Thinking, Process approach and Continual improvement for Medical Devices and related products
  • QSE consulting with ISO 13485, ISO 10993-1 and MDSAP ensures adequacy of all resources such as competent personnel assigned to tasks, accurate and calibrated instruments for measurement, systematically maintained equipment, evidence to show congenial working environment and methods to preserve and acquire organizational knowledge as required
  • QSE consulting with ISO 13485, ISO 10993-1 and MDSAP ensures documentation to have process controls during operations, methods to monitor input and outputs of facility’s operations, externally provided processes & products and controls during release of the product to customer
  • Management system developed during ISO 13485 by QSE, provides a perfect tool for top management to measure performances of all key processes, identify trends both positive and negative.
  • As a part of ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting QSE provides for Internal auditing services covering one full set of the selected standard and conducts an audit more stringent than Certification audit
  • ISO 13485 consulting, ISO 10993-1 consulting and MDSAP consulting by QSE provides means for controlling nonconformities and pave way for continual improvement
  • QSE Guarantees ISO 13485 certification or ISO 10993-1 certification or MDSAP certification when all 10 steps advised by QSE are followed
  • To achieve ISO 13485 certification or ISO 10993-1 certification or MDSAP certification all organizations must procure related medical device standards
  • Conduct Gap analysis using Audit Checklists for ISO13485, ISO 10993-1 and MDSAP
  • Develop a documented medical device quality management system to meet requirements of ISO 13485, or ISO 10993-1 or MDSAP
  • Implement the ISO 13485 Quality Management System or ISO 10993-1 Quality Management System or MDSAP Quality Management System and gather evidence of conformity
  • Conduct Internal Audits ISO 13485 standard using ISO 13485 Audit checklists and FDA/ MDSAP Audit checklists and ISO 10993-1 Audit checklists to ensure all elements of the relevant standard have been covered or not
  • Select an accredited Certification Body to conduct a stage 1 audit on your documentation for the quality management system developed for ISO 13485 standard, ISO 10993-1 standard or MDSAP standard
  • Make corrections to the documentation to ISO 13485 standard, ISO 10993-1 standard or MDSAP standard, if required based on stage 1 audit findings
  • Implement and gather evidence of conformity for about three months for ISO 13485 compliance, ISO 10993-1 compliance or MDSAP compliance
  • Invite the same accredited Certification Body for ISO 13485 certification audit, ISO 10993-1 certification audit or MDSAP certification audit
  • Make corrections to any nonconformities indicated by certification body and submit the same to certification body
  • Obtain clearance and get recommendation for obtaining ISO 13485 certification or ISO 10993-1 certification or MDSAP certification
  • Receive ISO 13485 certificate or ISO 10993-1 certificate or MDSAP certificate from Certification Body

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FAQ

Frequently Asked Questions​

Generally Medical devices are classified in to 3 categories of Class I, Class II, and Class III

Class I medical Devices is a medical device which has no Human/Animal contact or very brief contact such as Stethoscope, Bedpan etc.

Class II medical devices are the devices which have contact with Human body for more than 24 Hours Crutches, Knee Caps Teeth Braces etc. can come in this category

Class III are devices which have lasting contact with human body which include implantable devices such as embedded joint parts, Pace makers, dental implants etc.

Class I and Class II medical devices alone can get exemptions under FDA rule 501(K). The exemptions are about regulatory conditions to be followed for FDA compliance

Size of the company does not matter because all companies small or big or large corporations; must follow same requirements for certification. QSE utilizes all resources at its command to meet deadlines given by your customer within the frame work of practical feasibility. However, Certification Bodies usually require a minimum of 3 months of data for certification. Subject to availability of Certification Bodies, QSE leaves no stone unturned to meet the Target dates.

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Bhaskar Kotte

Baskar Kotte

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