(EN) ISO 13485:2016

Medical Device component manufacturers, finished good manufacturers, Medical Software developers, Medical Device designers and Developers, and pharmaceutical suppliers interested in enjoying worldwide presence must prove their devices are manufactured under certain auditable standards, which means it’s safe and effective. ISO 13485:2016 Certification is a solution for this issue!!!

Regulatory authorities in most major markets like European Union, United States, Canada, Japan, and Taiwan require, or strongly prefer, that manufacturers marketing medical devices in their countries have a third-party audited and certified Medical Device Quality Management System in place. An ISO 13485:2016 compliant system expedites access into those countries that require it.

ISO 13485:2016 Certificate will be issued by an accredited third-party after assesses your compliance towards Medical Device Quality Management System. We are there to help you in the training, documentation, implementation, and internal audit. You will be getting much useful information while you continue reading our website.

Benefits of ISO 13485:2016 Certification

Adopting this standard is beneficial to the organization in many ways:-

  • Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.
  • ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices. All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization.
  • Companies that achieve ISO 13485 certification enjoy the benefits of an increased number of customers who have more reason to trust and purchase consistently high-quality products.
  • ISO 13485 will benefit customers, suppliers, management, and especially workers
  • Rapid and effective communication, feedback, and recognition on efforts made results achieved, and work to be done.
  • Continuous assessment, improvement, and re-registration of systems.
  • ISO 13485 certification is advantageous to medical device companies that export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical for the medical device industry.
  • ISO 13485 compliant management systems adopt a risk management approach that includes an assessment to identify & estimate risk, uses risk controls and techniques to eliminate hazardous situations throughout product realization.
  • Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.
  • Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace.

ISO 13485 Implementation & Procedure

We have developed a nine-stage ISO 13485: 2016 implementation program. Sincere effort and dedicated team guarantee successful completion and certification through our consultancy.

Stage 01 > Appoint consultants – Well experienced in Medical device certification. Knowledge in FDA, MDD, and GMP have added advantages for the consultants.
Stage 02 > Perform a 13485 GAP Analysis – If the organization already implemented ISO 9001 quality management system. This is not required for those implementing the first time.
Stage 03 > Project Schedule – Consultants will work with the acting MR to prepare a project schedule. The schedule will list the actions needed. The Process Owners will be informed about their duties and responsibilities along with the timeline.
Stage 04 > Develop Process Mapping – Consultants will guide you to develop Process Mapping. There will be 2 levels of Process Maps:

  • Define process interactions.
  • Process Mapping based on its own.
Stage 05 > Develop Documentation Consultants will identify the required documents. This will include:

  • Quality Manual.
  • QMS procedures.
  • Protocols, Forms, Formats, Records, Reports etc.
Stage 06 > Employee Training Consultants will help you identify the training needs of your employees. Consultants will provide training for all levels of people in the organization like awareness, GMP, and internal auditor training.
Stage 07 > Implementation Do what you documented, document what you does/td>
Stage 08 > Establish quality goals and understand how they can best be incorporated into your business operations.
Stage 09 > Internal Audit – Consultants will provide internal audit along with certified internal auditors.
Stage 10 > Certification Audit – Consultants will be present during the day of the certification audit to help the in-house team…

ISO 13485:2016 Requirements

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Clause 1: Scope A Quality Management System for an organization that provides medical devices and services that meets customer requirements.
Clause 2: Normative Reference ISO 9000:2005 which should be used along with ISO 13485 standards. It outlines the Quality Management Systems-Fundamentals and Vocabulary
Clause 3: Terms and Definitions Gives definitions used in the standard, many of which are in addition to ISO 9001.

  • In-vitro diagnostic reagents
  • Software medical device
  • Class of Medical Device
  • Active Implantable Medical Device
  • Active Medical Device
  • Advisory Notice
  • Customer Complaint
  • Implantable Medical Device
  • Labeling
  • Medical Device
  • Sterile Medical Device
Clause 4: General Requirements
  • Quality Manual with Scope of ISO 13485:2016
  • Required Procedures
  • Required Forms & Records
  • Control of Documents
  • Control of Forms
Clause 5: Management Responsibility
  • Management Responsibility
  • Quality Policy & Objectives
  • Customer Focus & Customer Satisfaction
  • Management Review
Clause 6: Resource Management
  • Personnel & Training
  • Resource Management
Clause 7: Product Realization
  • Production of the product or service
  • Planning
  • Customer related processes and Customer Feedback
  • Design
  • Purchasing
  • Process control
  • Identification and Traceability
  • Customer Property
Clause 8: Measurement, Analysis and Improvement
  • Requirements on monitoring processes to improve
  • Customer Satisfaction
  • Internal Audits
  • Control of Non-Conforming Product
  • Corrective and Preventive Action

ISO 13485 Consultants

Medical Device Quality Management Systems, also known as ISO 13485:2016 or EN ISO 13485:2016, must be enforced for regulatory purposes by those involved in the manufacturing, design, distribution, servicing, testing, or sterilization of medical devices.

Since the ISO 13485 implementation is primarily for regulatory purposes, the role of ISO 13485 consultants is critical. By way of the latest Harmonized Standards, the European Medical Device Directive or New Medical Device Regulation for CE Marking mandates EN ISO 13485:2016. At this time, EN ISO 13485:2016 Consultants is important. I’d like to draw your attention to the fact that an ISO consultant and a medical device regulatory consultant are not the same things. An experienced ISO 13485 Consultant will always be able to provide accurate technical and scientific knowledge.

You can hire a QMS ISO consultant if you’re just a distributor and don’t intend to apply CE Marking, but if you want to CE Mark your device, EN ISO 13485:2016 implementation is required and should be planned in accordance with MDR /IVDR guidelines. As a result, manufacturers seeking CE Marking or FDA clearance must hire regulatory consultants with experience implementing EN ISO 13485:2016.

In order to be enforced and accredited, the general EN ISO 13485:2016 enforcement criteria include several required procedures and record forms, all of which must be checked, authorized, retained, and revised to remain in compliance. To ensure complete compliance with the EN ISO 13485:2016 standard, we specialize in document drafting, training, support, analysis, and internal auditing for all manufacturing and related services. We can also design paper systems, electronic systems, or even web-based document management systems that can be accessed from anywhere in the world and customized to your organization’s structure and needs.

EN ISO 13485:2016 plays a critical role, as the standard was updated and released on March 1, 2016. IAF Resolution 2015-13 specifies a three-year transition period from the date of publication.

As ISO 13485 consultants, we primarily work with medical device and IVD businesses, so we are familiar with the industry’s specific requirements and manufacturing scenarios. EN ISO 13485:2016 lead auditors and certified internal auditors are among our ISO 13485 consultants. Our ISO 13485 consultants tailor your ISO 13485 quality framework to your organization’s unique requirements and ensure that you are ready for an ISO 13485 certification audit by a Certification Body.

Our ISO 13485 consulting, few benefits are listed below:

  • Qualified and experienced medical device ISO 13485 consultants
  • EN ISO 13485:2016 Consultants are certified, Lead Auditors
  • Largest fool of full-time ISO 13485 consultants
  • Largest reference standard and document collection
  • Offsite (online) ISO 13485 consultancy with very normal fee
  • Payments based on deliverables.
  • Good reputation with all Certifying bodies.

ISO 13485 Implementation and Certification timeline

In a mid-sized company of 30 workers, it takes about 4 weeks to draught the paperwork after hiring I3CGlobal, and another 4 to 6 weeks to implement. Larger companies with more than 50 staff and/or several locations can take longer. The availability of the Certification Body and its certified auditors to inspect and certify your business also affects the certification timeline.

EN ISO 13485:2016 Consultation Fees

(Consulting, Implementation, Internal Audit, GAP Analysis, Training fees )

Medical Device Manufacturers ( OEM & OBL), Traders & Exporters can avail themselves of our services across the globe.

Type of Service and Fees

[A] OFFSITE Custom made the drafting of documents

    1. ISO 13485:2016 – Quality Manual & Mandatory Procedures with important templets in 20 working days – 1199 USD
    1. ISO 13485:2016 Quality Manual in 5 working days – 499 USD
  1. ISO 13485:2016 Mandatory Procedures with Important Forms in 15 working days – 999 USD

Important

  • Payment – 60% advance, 40% before document handover.
  • Method of communication – Telephone / Skype / G talk.
  • The language of communication is English.
  • Documentation using an external Cloud server (DROPBOX).

[B] ONSITE IMPLEMENTATION SUPPORT

    1. ONSITE Man day FEES – 350 USD
    1. ONSITE Training & Quality Audit (IQA) FEES – 450 USD
    2. (1 Man day = 7Hrs)
Important
  • Consultants travel across the Globe from Bangalore, India OR Chicago, USA.
  • Payment – 50% before the visit and 50% after the visit.
  • Travelling & Lodging additional
  • Documentation using an external Cloud server.
  • Taxes applicable as per Government rules.

Please Fill the Request For Quote (RFQ) here

EN ISO 13485:2016 Certification Fees

The cost of ISO 13485 Certification Cost depends on 3 factors:

  • (A) Number of full-time employees
  • (B) Number of devices manufactured in the facility
  • (C) Number of activities carried in the facility with design and without design
  • (D) Shop floor area

Cost of Certification Body

This certification cost depends on the following factors

  • Number of Employees
  • The complexity of the medical device and variants
  • Certification Body selected
  • Travelling fees
  • Auditor accommodation and daily expenses
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