At Landmark Research, we are committed to the highest quality assurance standards in every aspect of our services. As a leading player in the medical device industry, we understand the critical importance of compliance with international regulations.

What is ISO 13485?

ISO 13485 is an internationally recognized standard specifically designed for medical device quality management systems. It outlines the requirements for a comprehensive quality management system that demonstrates an organization’s ability to consistently design, develop, produce, and deliver medical devices that meet regulatory and customer requirements.

Key Benefits of ISO 13485 Compliance:

  1. Enhanced Patient Safety: ISO 13485 ensures that the medical devices we work with are designed, manufactured, and maintained with the utmost focus on patient safety. This leads to improved patient outcomes and reduced risks.
  2. Stringent Quality Standards: Our adherence to ISO 13485 guarantees that our processes and procedures consistently meet or exceed the highest quality standards, promoting confidence among stakeholders and regulatory bodies.
  3. Efficient Operations: A robust quality management system streamlines our operations, reducing inefficiencies and errors. This ultimately translates into faster product development timelines and quicker time-to-market.
  4. Global Market Access: ISO 13485 is internationally recognized, opening doors to global markets and partnerships. This compliance gives us a competitive edge, allowing us to work seamlessly with clients and regulatory agencies around the world

Our Quality Assurance Approach:

Our team of experienced professionals is well-versed in ISO 13485 requirements and best practices. We meticulously integrate quality control measures into every stage of the product lifecycle – from initial design and development to testing, validation, and ongoing post-market surveillance.

What do we do?

  • Identify the QMS standard requirements
  • Identify the legal and regulatory requirements based on the classification of the product
  • Plan for establishing the standard requirements stage-wise
  • Developing and defining the processes and their documentation
  • Providing training to the QMS team
  • Implementing the QMS
  • Developing a continual improvement approach in the whole QMS
  • Evaluating the effectiveness of the QMS implemented

CE Marking

Here, we understand that achieving CE marking for your medical device is a critical milestone on your journey to market success. Our expert team is dedicated to guiding you through the complex regulatory landscape, ensuring that your device meets the stringent requirements set forth by the European Union (EU).

What are the Requirements for Obtaining CE Marking for Medical Devices?

To obtain CE mark for medical devices, the following steps need to be taken:

  • Classify your device based on its risk level, body placement, and duration of use. The classification ranges from Class I (low risk) to Class III (high risk).
  • Medical device manufacturers must have at least one person responsible for regulatory compliance within the company. And this person needs to have expertise in the field of medical devices.
  • Establish a quality and risk management system that meets the requirements of the EU Medical Device Regulation (MDR). Many companies adopt the ISO 13485 standard for this purpose.
  • Create detailed technical documentation, also known as medical device technical documentation for MDR, that provides information about the device’s design, specifications, manufacturing, safety, and performance. Ensure the documentation is well-organized and compliant with MDR requirements.
  • Develop a system to manage and evaluate your suppliers to ensure they meet the necessary requirements and standards. Maintain a list of approved suppliers and conduct audits as needed.
  • Perform a clinical evaluation to demonstrate that your device conforms to safety and performance requirements. Gather and analyse clinical data from relevant scientific literature and clinical investigations.
  • If your company is located outside the European Economic Area (EEA), appoint an authorized representative within the EEA to handle certain responsibilities, such as verifying technical documentation and addressing complaints.
  • Engage with a Notified Body, an independent organization designated to assess the conformity of medical devices. The Notified Body will audit your quality management system and technical documentation to ensure compliance with MDR requirements. Certification is mandatory for higher-risk devices.
  • Once certified by a Notified Body, issue a Declaration of Conformity stating that your device meets all applicable requirements of the MDR.
  • Assign a unique device identifier (UDI) to your device and register it in the European Database on Medical Devices (EUDAMED) for traceability purposes.
  • Display the CE marking on your device, packaging, and instructions for use. The marking must be clearly visible, readable, and durable. For Class II and III devices, include the identification number of the Notified Body alongside the CE marking.
  • Establish a system for post-market surveillance to monitor the device’s performance and safety once it is on the market. Continuously collect and evaluate data, address complaints and adverse events, update safety reports, and keep documentation up to date.

What is CE Marking?

CE marking is a certification that indicates a medical device’s compliance with the essential health and safety requirements outlined in the European Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). It is a declaration by the manufacturer that the device conforms to these regulations, allowing it to be legally marketed and distributed within the European Economic Area (EEA).

Why Choose Us for CE Marking?

Navigating the regulatory process and preparing the necessary documentation for CE marking can be a daunting task. Our experienced professionals specialized in regulatory affairs and quality assurance, and we are well-versed in the intricacies of the MDR. Here’s how we can help:

  • Regulatory Consulting
  • Comprehensive Regulatory Expertise
  • Tailored Documentation
  • Risk Management
  • Clinical Evaluation
  • Clinical Trials Management
  • Quality Management System
  • Risk Management
  • Post-Market Surveillance

What is GDPR?

  • General Data Protection Regulation(GDPR) encompasses the protecting the rights of EU citizens by enhancing privacy and minimizing the risk of data breaches.
  • GDPR applies to any information that could be used to identify someone in the EU, either directly or indirectly—also known as personally identifiable information (PII).
  • Any organization that processes PII must abide by seven data protection principles laid out in Article 5.1-2 of the regulation:
    1. Lawfulness, fairness, and transparency
    2. Purpose limitation
    3. Data minimization
    4. Accuracy
    5. Storage limitation
    6. Integrity and confidentiality
    7. Accountability
  • GDPR also requires data protection “by design and by default”, which means that every organization that deals with personal data must consider these data protection principles while designing any new product or service

GDPR compliance in clinical trials

  • GDPR states that a clear and documented consent must be acquired from all data subjects in order to process their information.
  • Medical device companies, or clinical trial sponsors, must now identify the data to be processed, where it will be transferred to, who is processing it, what it will be used for, and which risks are involved.
  • Organizations that process and manage clinical trial data must now conduct data impact assessments(DIA) on both electronic and hard copy data.
  • Sponsors are also required to appoint a Data Protection Officer(DPO) which shall take part in managing and documenting many of the activities that surround data and information processing. In addition, the DPO will also act as the main interface to the company if there are any data breaches or inbound inquiries.

GDPR does provide some exemptions regarding provisions like the right to be forgotten in certain cases. For instance, clinical trial data is considered “special data”, because processing of such data is necessary for research-specific purposes.

What do we do?

  • Data Privacy Impact Assessment (DPIA): Assessment of the potential risks to data subjects’ privacy when processing personal data and recommend mitigation measures.
  • Data Protection Officer (DPO) Services: Ensuring GDPR compliance, managing data protection policies, and serving as a point of contact for data protection authorities.
  • Data Processing Agreements (DPAs): Drafting, negotiating, and maintaining DPAs with data processors and sub-processors to ensure that data processing activities are GDPR-compliant.
  • Consent Management: Developing and managing consent forms and processes for obtaining valid and informed consent from research participants or patients.
  • Data Collection and Handling: Ensuring secure and compliant data collection, storage, transmission, and disposal throughout the research process.
  • Privacy by Design: Integrating data protection measures into the design and development of research protocols, data management systems, and technology solutions.
  • Data Anonymization and Pseudonymization: Implementing techniques to anonymize or pseudonymize personal data to reduce privacy risks while maintaining data utility.
  • Subject Rights Management: Managing data subject rights, such as the right to access, rectify, and delete personal data, as well as handling data subject requests.
  • Data Security: Implementing robust technical and organizational measures to safeguard personal data against breaches and unauthorized access.
  • Data Breach Response and Reporting: Developing and implementing procedures for detecting, reporting, and responding to data breaches in accordance with GDPR requirements.
  • Records of Processing Activities: Maintaining records of processing activities as required by GDPR and assisting in keeping these records up-to-date.
  • Regulatory Compliance: Ensuring overall regulatory compliance with GDPR and other relevant data protection laws in the context of clinical trials and research.