Comprehensive Medical Device Consulting for Regulatory Success and Market Excellence

Optimize Your Medical Device Compliance with Valicare’s Specialized Consulting Services

Navigating the complexities of regulatory compliance in the medical device industry requires precision, expertise, and a deep understanding of both regional and international standards. Valicare is your partner in ensuring full compliance with the EU MDR, FDA, and other major global regulatory requirements. We offer tailored support for manufacturers aiming to meet the stringent demands of the medical device market.

Our Core Compliance Services:

• MDR Compliance
  We guide you through the complicated landscape of the EU Medical Device Regulation (MDR), ensuring your products adhere to strict European standards. Our expertise encompasses all MDR requirements, from technical documentation to Post-Market Surveillance (PMS), guaranteeing you a streamlined path to EU market approval.
• FDA Compliance
  Entering the U.S. market requires alignment with FDA regulations. Valicare supports you in establishing compliant Quality Systems per FDA’s 21 CFR Part 820 and assists in FDA premarket notifications (510(k)), Premarket Approval (PMA), and other regulatory submissions for efficient access to the U.S. medical device market.
• Compliance with International Regulations
  In addition to MDR and FDA, we assist in meeting regulatory requirements for other major markets, including Japan, Canada, and Australia, helping to streamline your global market entry.

Contact us today to learn how Valicare can support your journey toward compliance, innovation, and excellence in the medical device sector.

Systematically applied quality risk management ensures the consistent performance of processes and the high quality of products.

Valicare supports companies of the medical device industry in fulfilling the central requirements of national and international regulations such as EN ISO 13485, 21 CFR Part 820 with cGMP, GHTF documents, or GAMP 5 using a risk-based approach.

Quality risk management is applied in the general consideration of the criticality of processes in the QM system. The GMP-compliant qualification of equipment and systems as well as validation to demonstrate the reproducibility of manufacturing processes, cleaning methods, analytical methods, and computerized systems is based on a risk-based approach. The criticality determines the depth of the respective test efforts.

Valicare's services in this area are at the highest professional and technical level.

Enhance Your Medical Device Safety with Comprehensive Risk Management Services

In the medical device industry, ensuring patient safety and regulatory compliance is essential. Implementing a robust risk management framework in line with EN ISO 14971 is necessary for identifying, evaluating, and mitigating potential risks throughout a device's lifecycle. At Valicare, we specialize in guiding manufacturers through the complexities of risk management, ensuring your products meet the highest safety standards and comply with global regulations.

Our EN ISO 14971 Risk Management Services Include:

• Risk Management Process Development
  We assist in establishing a comprehensive risk management process tailored to your organization's needs, encompassing risk analysis, evaluation, control, and monitoring activities as outlined in EN ISO 14971.
• Risk Identification and Analysis
  Our experts facilitate systematic identification of potential threats associated with your medical devices, conducting thorough risk analyses to assess the probability and severity of harm.
• Risk Evaluation and Control Implementation
  We support you in evaluating identified risks against acceptable criteria and implementing effective risk control measures to mitigate or eliminate them, ensuring compliance with regulatory requirements.
• Documentation and Reporting
  We provide guidance on maintaining detailed risk management documentation, including risk management plans, reports, and records, to demonstrate compliance during audits and regulatory submissions.
• Training and Education
  Empower your team with our tailored training programs on risk management principles, EN ISO 14971 requirements, and best practices for maintaining a culture of safety and compliance within your organization.

Partnering with Valicare ensures that your risk management processes are robust, compliant, and effectively integrated into your quality management system. Our dedicated team of specialists brings extensive industry experience, providing personalized solutions that enhance the safety and reliability of your medical devices.

Contact us today to learn how we can support your journey toward comprehensive risk management and regulatory compliance in the medical device sector.

Optimize Your Medical Device with Comprehensive Usability Engineering Services

In the medical device industry, usability plays a critical role in ensuring patient safety and device effectiveness. Adopting a structured usability engineering process, as outlined in IEC 62366-1, is essential for identifying and minimizing user-related risks throughout the product lifecycle. At Valicare, we provide specialized consulting services to help manufacturers design intuitive, user-friendly medical devices that meet regulatory requirements and enhance user experience.

Our IEC 62366 Usability Engineering Services Include:

• Usability Engineering Process Implementation
  We help establish a usability engineering framework tailored to your organization, focusing on identifying and addressing potential user errors in compliance with IEC 62366-1.
• User Needs and Task Analysis
  Our experts conduct in-depth analyses to understand user needs, intended uses, and operational contexts, forming the foundation for safe and effective device design.
• Usability Risk Assessment
  We identify potential usability risks that could compromise safety or performance, evaluating the probability and severity of harm to ensure risks are effectively mitigated.
• Formative and Summative Evaluations
  Valicare supports iterative usability testing during the design phase (formative evaluations) and final validation testing (summative evaluations) to ensure your device meets user expectations and regulatory standards.
• Human Factors Documentation
  We assist in creating and maintaining comprehensive usability engineering files, including use specifications, risk analyses, validation reports, and records required for regulatory submissions.
• Training and Support
  Empower your team with tailored training programs on usability engineering principles, IEC 62366 requirements, and best practices for designing user-centered medical devices.

Why Choose Valicare for Usability Engineering?

At Valicare, we understand the critical importance of user-centered design in the medical device industry. Our expertise in IEC 62366 compliance ensures that your devices are safe, intuitive, and effective for end-users. We work closely with your team to deliver tailored, high-quality solutions that integrate usability engineering seamlessly into your development process.

Contact us today to discover how we can enhance the usability and market success of your medical devices and set new benchmarks for safety and usability.

Ensure Medical Device Safety with Comprehensive Biocompatibility Assessment Services

In the medical device industry, ensuring that materials are safe for human use is a critical regulatory requirement, especially under the MDR ((EU) 2017/745). Complying with ISO 10993, the international standard for biological evaluation of medical devices, is essential to assess biocompatibility and minimize risks to patients. At Valicare, we provide specialized consulting services to help manufacturers meet these requirements, ensuring product safety and regulatory compliance.

Our ISO 10993 Biocompatibility Services Include:

• Biological Risk Assessment
  We conduct profound evaluations to identify potential biological risks associated with your device materials, ensuring compliance with ISO 10993 standards and regulatory expectations.
• Material Characterization
  Our experts help analyze device materials for physical, chemical, and toxicological properties to identify potential interactions with human tissue, a key step in biocompatibility assessment.
• Biocompatibility Test Planning
  Valicare assists in designing a tailored testing strategy, determining the appropriate in vitro and in vivo tests required to assess cytotoxicity, sensitization, irritation, and more, based on the device's risk classification.
• Regulatory Documentation and Submission Support
  We provide guidance on compiling detailed biocompatibility documentation, including biological evaluation plans, test reports, and risk assessments, ensuring successful submissions to regulatory authorities like the FDA, EU MDR, and others.

• Gap Analysis and Remediation
  We evaluate your existing biocompatibility data to identify gaps and recommend strategies for remediation to align with current ISO 10993 requirements.
• Training and Education
  Empower your team with tailored training programs on ISO 10993 principles, biological risk management, and compliance best practices, fostering a culture of safety and regulatory excellence.

Why Choose Valicare for Biocompatibility Consulting?

At Valicare, we combine deep expertise in material safety with a commitment to excellence, ensuring that your medical devices meet the highest biocompatibility standards. Our personalized solutions help streamline the evaluation process, minimize regulatory issues, and safeguard patient health.

Contact us today to learn how Valicare can support your biocompatibility assessment and regulatory compliance needs in the medical device sector.

Qualification and validation ensure the quality of medical devices

We provide qualified equipment and validated manufacturing processes that ensure reproducible high quality of medical devices.

Medical device manufacturers must ensure that their medical devices meet high quality standards to satisfy regulatory requirements and protect patients. It is therefore advisable to comply with these requirements already during development and to consider them in all further process and manufacturing steps.

After successful design verification and design validation, during which we can advise and accompany you, manufacturing the medical device is the next hurdle. Manufacturers must ensure that the quality of the product is reproducible.

Our experts will be happy to help you overcome this challenge.

Additional information about our validation and qualification services for medical devices can be found here: Qualification & Validation in the Medical Device Industry | Valicare GmbH.