FAQ

Supporting Medical Device Startups for Success

How can your support program benefit my medical device startup?

Our support program offers comprehensive services tailored to the unique needs of medical device startups. From regulatory compliance to testing support and supplier development, we help you navigate challenges and accelerate your path to success.

How do I get started with your support program?

Simply reach out to our team through the contact form on our website or give us a call. We will schedule an initial consultation to understand your specific needs and tailor a support plan that aligns with your goals.

Do you have success stories or client testimonials?

Yes, we have a proven track record of helping medical device startups thrive. Visit our testimonial page to hear directly from our satisfied clients who have experienced the value and impact of our support programs.

Internal Audit Service on ISO 13485, MDSAP, and EU MDR

What are the key regulatory requirements under EU MDR, ISO 13485, and MDSAP?

The key regulatory requirements include conformity assessment, risk management, post-market surveillance, quality management systems, labelling, Testing and clinical and biological evaluations.

What are the key elements of an effective internal audit program?

An effective internal audit program should include clear audit objectives, competent auditors, comprehensive audit plans, systematic evaluation of processes, thorough documentation, and timely follow-up on findings.

What is the importance of testing medical devices according to the IEC 60601 series of standards?

Testing medical devices according to the IEC 60601 series of standards ensures their safety, performance, and compliance with electrical and electronic requirements, promoting patient and user safety.

What types of testing services are typically performed for compliance with the IEC 60601 series of standards?

Common testing services for compliance with the IEC 60601 series of standards include electrical safety testing, electromagnetic compatibility (EMC) testing, usability testing, and performance testing.

Are there specific software solutions available to aid in regulatory compliance management?

Yes, there are regulatory compliance management software solutions available that facilitate document control, risk management, complaint handling, audit management, and overall compliance tracking.

What steps should be taken to ensure proper labelling and instructions for use of medical devices?

Ensuring proper labelling and instructions for use requires compliance with labelling regulations, adherence to international standards, accuracy in content, translations if necessary, and usability testing for clarity and comprehension.

How can we prepare for regulatory inspections and audits?

Preparation for regulatory inspections and audits includes maintaining up-to-date documentation, conducting internal audits, addressing previous audit findings, training staff, and being aware of regulatory requirements and changes.

How can we stay updated with the latest regulatory changes and ensure on going compliance?

Staying updated involves actively monitoring regulatory agencies’ communications, participating in industry conferences and forums, engaging with regulatory experts, and subscribing to reliable regulatory updates to ensure on going compliance and timely adaptations.

How can our organization achieve and maintain compliance with EU MDR, ISO 13485, and MDSAP?

To achieve and maintain compliance, it is crucial to establish robust quality management systems, conduct regular internal audits, stay updated on regulatory changes, and engage in continuous improvement practices to remain state-of-the-art.

How often should internal audits be conducted?

Internal audits should be conducted at regular intervals, typically annually or biannually, although the frequency may vary based on the organization’s risk profile and regulatory obligations.

Can you provide guidance on conducting risk assessments in line with regulatory requirements?

Yes, our organization offers expertise in conducting risk assessments according to regulatory standards, such as ISO 14971, to identify and mitigate potential risks associated with medical devices.

How can we select an appropriate independent accredited laboratory for testing our medical devices?

Selecting an independent accredited laboratory involves considering factors such as their expertise, accreditation status, track record, testing capabilities, adherence to standards, and turnaround time.

How can we ensure that our medical devices comply with the ISO 10993 series of standards for biological evaluation?

Compliance with ISO 10993 standards for biological evaluation can be achieved through a study document, conducting biocompatibility testing, including cytotoxicity, irritation, sensitization, and systemic toxicity assessments.

What are the benefits of using software solutions for document control in a regulatory compliance organization?

Using software solutions for document control streamlines the management of policies, procedures, work instructions, and records, ensuring version control, accessibility, and traceability, and supporting compliance with regulatory requirements.

What is the process for obtaining and maintaining CE marking for medical devices under the EU MDR?

The process involves conformity assessment, preparation of technical documentation, demonstration of compliance with applicable requirements, involvement of notified bodies (if applicable), and affixing the CE mark.

What are the consequences of non-compliance with EU MDR, ISO 13485, and MDSAP requirements?

Non-compliance can lead to product recalls, fines, legal actions, damage to reputation, loss of market access, and potential harm to patients or users.

Manage Your Complaint Handling Process through KPO

How can we establish effective processes for complaint handling and adverse event reporting?

Effective processes for complaint handling and adverse event reporting involve clear procedures, efficient record-keeping, timely investigations, appropriate risk assessments, and compliance with reporting obligations as per regulatory requirements.

Support for PMS, PMCF, and PSUR Activities

Can you provide guidance on post-market surveillance and vigilance reporting obligations?

Yes, we can provide guidance on establishing robust post-market surveillance processes, monitoring device performance, collecting and analysing feedback, and complying with vigilance reporting requirements.

Are there specific requirements for post-market clinical follow-up studies?

Yes, post-market clinical follow-up studies may be required for certain medical devices to collect additional clinical data, assess device safety and performance, and ensure on going compliance with regulatory requirements.

Safetek Regulatory

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