Service 2.1

Third Party Audit and Certification Services

Improving quality and maintaining safety, is the best way for an organization to achieve the required results, thus enabling them to raise their profile and grab new opportunities. Certification of a management system helps to achieve this and provides evidence to the customers and the market, about the client's compliance towards the international standards. Hence, a successful audit and certification process, is the outcome of a prompt third-party certification body such as DI Quality Certification Services Pvt.Ltd.

We at DI Quality Certification Services Pvt.Ltd. provide Audit and Certification services Third party Audit, Certification, Surveillance and Recertification services for ISO 9001 and ISO 13485 standard.

Service 2.2

Training

List of Trainings provided by us:

ISO 9001 Quality management systems - Requirementsawareness training
ISO 9001 Quality management systems - Requirements Internal auditor training
ISO 9001 Quality management systems - Requirements Lead auditor training
ISO 9001 Quality management systems for medical devices - awareness training
ISO 13485 - Rquality management systems for medical devices Internal auditor training
ISO 13485 Quality management systems for medical devices - Lead auditor training
EU Medical Device Regulation - Introduction training course
EU Medical Device Regulation implementation training course
EU IVD Medical Device Regulation - Introduction training course
US FDA 21 CFR requirements - Introduction training course
Introduction to Medical devices - Application of risk management to medical devices-ISO 14971
Introduction to EN ISO 11135 part 1 and part 2 Sterilization of health care products - Ethylene oxide
Introduction to EN ISO 11137 part 1 and part 2 Sterilization of health care products - Radiation
Introduction to EN 10993-1 , Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process

Service 2.3

MDR 2017/745 and IVDR 2017/746 Assessments

At DI Quality Certification Services Private Limited, we are committed to providing high-quality assessment services for medical devices and in vitro diagnostic devices in accordance with the latest European regulations.

Our expert team conducts thorough evaluations to ensure compliance with the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746.

MDR 2017/745 Assessment - We perform comprehensive assessments of technical files for medical devices to verify conformity with the MDR 2017/745 requirements. This includes a detailed review of design, manufacturing processes, clinical evaluations, and post-market surveillance activities.
IVDR 2017/746 Assessment - Our services also encompass detailed evaluations of technical files for in vitro diagnostic devices, ensuring adherence to IVDR 2017/746 standards. We assess documentation related to device performance, safety, clinical evidence, and quality management systems.

Commitment to Impartiality and Conflict of Interest Management

To maintain the highest standards of impartiality and integrity, we adhere to strict conflict of interest management practices:

Independent Assessment: Our assessments are conducted by dedicated professionals who have no financial or personal interests in the devices or companies being evaluated. We ensure that our assessment teams operate independently and impartially throughout the evaluation process.
Conflict of Interest Policies:Our organization has implemented robust policies and procedures to identify and manage any potential conflicts of interest. All team members are required to disclose any potential conflicts and adhere to our strict guidelines to ensure unbiased decision-making.
Transparency and Accountability: We are committed to transparency in our processes. Any potential conflicts are promptly addressed, and our procedures are regularly reviewed to maintain the integrity of our assessments.
Ongoing Training: Our assessors receive regular training on conflict-of-interest management and impartiality to stay updated on best practices and regulatory requirements.