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MedTech

Our team of MedTech consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements

MedTech

Increased complexity in the Medical Devices regulatory landscape is generating greater challenges that need to be addressed in order to maintain a  competitive position in the market.

Asphalion’s solutions for Medical Devices cover a full range of technological segments, such as: Implants, Wound-care, Wearables, IVDs, Software as Medical Device, Substance based and Drug Device Combinations, among others.

Starting from a proof of concept, throughout the design & development process, product approvals and maintenance of the device in the market, Asphalion can provide you with full Regulatory and Quality Management System (QMS) support for a time to market optimisation by minimising regulatory setbacks since the very beginning.

MedTech Solutions

Our Medical Device services include:

  • Customised regulatory roadmaps under MDR/IVDR requirements
  • Feasibility assessments and qualification & classification analyses
  • Critical review of clinical and preclinical development strategies
  • Regulatory product plans and reports (including design & development, risk management, verification and validation, clinical evaluation and performance evaluation, software life-cycle management, biocompatibility assessment and usability)
  • Support in the selection of adequate Notified Body
  • Expert advice in EU-funded projects
  • Gap analysis of Technical Documentation under MDR/IVDR requirements
  • Compilation or update of Technical Documentation under MDR/IVDR requirements
  • Writing of specific modules, including General Safety and Performance Requirements (GSPRs) Checklist, IFUs and labelling, etc.
  • Writing and update of Clinical Evaluation Plans and Reports under MDR requirements
  • Writing and update Performance Evaluation Plans and Reports under IVDR requirements
  • Support in definition or gap analysis of PMS system under MDR/IVDR requirements
  • PMS implementation, including SDEA elaboration, events and complaints management, safety alerts screening, etc.
  • Elaboration of PMS reports and PSURs
  • Definition and implementation of action plan in regards to non-conformities from Notified Bodies
  • Strategic advice for QMS definition (scope, policy, list of procedures, etc.)
  • Elaboration and review of Standard Operating Procedures and other quality documentation according to Client’s needs
  • QMS trainings
  • Management review meetings
  • Online and onsite Internal Audits
  • Online and onsite third-parties Audits (suppliers, manufacturers, distributors, etc.)
  • Support during Notified Body Audits
  • Definition and implementation of action plan in regards to CAPAs

The PRRC, or Person Responsible for Regulatory Compliance, is a new role introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The PRRC is responsible for ensuring that a medical device manufacturer complies with all applicable EU regulations. This includes ensuring that the manufacturer’s quality management system (QMS) is compliant, that the devices are designed and manufactured safely, and that they are properly marketed and post-market surveillance.

The PRRC must have the following qualifications:

  • A university degree or equivalent in a relevant field, such as, engineering, or law.
  • At least 3 years of experience in regulatory affairs for medical devices.
  • Knowledge of the EU MDR and IVDR.
  • The ability to communicate effectively in English.
  • The PRRC must be permanently and continuously available to the manufacturer. This means that they must be able to respond to inquiries from notified bodies, competent authorities, and other stakeholders at any time.

The PRRC’s responsibilities include:

  • Overseeing the manufacturer’s QMS.
  • Ensuring that the manufacturer’s devices comply with all applicable EU regulations.
  • Preparing and submitting regulatory documentation, such as the Declaration of Conformity and the Technical Documentation.
  • Responding to inquiries from notified bodies, competent authorities, and other stakeholders.
  • Participating in audits and inspections.
  • Reporting on regulatory compliance to the manufacturer’s management.

 

The PRRC can be an employee of the manufacturer or a third-party consultant. If the PRRC is a third-party consultant, the manufacturer must enter into a contract with the consultant that specifies the consultant’s responsibilities and liabilities.

The PRRC is an important new role under the EU MDR and IVDR. By ensuring that manufacturers comply with all applicable regulations, the PRRC helps to protect patients and ensure the safety of medical devices on the EU market.

If you are a medical device manufacturer, you need to ensure that you have a qualified PRRC in place. If you do not have the in-house resources to provide this function, you can outsource the PRRC service to a qualified consultancy firm.

At Asphalion we can help you with your PRRC needs. We have a team of experienced regulatory experts who can provide you with the support you need to comply with the EU MDR and IVDR. We can help you with all aspects of the PRRC process, from qualification and appointment to day-to-day support. We can also help you with other regulatory affairs matters, such as product registration, documentation preparation, and audit support.

As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD:

  • Contact point with EU Competent Authorities and Notified Bodies
  • Support with Medical Device and IVDs registrations, as required
  • Keeping Technical Documentation and Declaration of conformity available upon Health Authorities request
  • Regulatory intelligence: stay always up to date on legislation changes and how they can affect your products

Why work with Asphalion?

  • Expert MedTech professionals
  • Good communication
  • Similar business culture
  • Strict confidentiality
  • Full life cycle support
  • Cost-effective solutions

As your UK Responsible Person we will not only assume the representative role with MHRA on your behalf, but also will provide you with:

  1. Responsiveness to any request and/or inspection from MHRA
  2. Support for the Registration of Medical Devices with the MHRA
  3. Regulatory Intelligence to monitor any change in local legislation
  4. Management of incidents and/or complaints
  5. Notification of incidents and/or complaints to MHRA
  6. Support for the UKCA approval for new and CE certified medical devices

 

With high knowledge and understanding of the EU and UK regulations and hence, their differences and synergies, we will assist you on establishing the best regulatory strategy considering the unique challenges and opportunities of the UK market.

The FDA requires that all foreign manufacturers have a US Agent to act as their official representative in the United States. At Asphalion, we offer comprehensive US Agent services for medical device manufacturers looking to expand their business in the US market.

As your US Agent, we provide:

  1. Assistance with FDA registration and listing requirements
  2. Expert guidance on US regulations and compliance requirements
  3. Support for post-market reporting obligations, including adverse events, corrections, and removals
  4. Coordination with FDA on behalf of the foreign manufacturer
  5. Assistance with communications with FDA, including responses to inquiries and requests for information

 

Our team of regulatory affairs experts has extensive experience working with medical device manufacturers and navigating the complex regulatory landscape in the US. We are committed to providing our clients with the highest level of service and support to ensure compliance with all relevant regulations and requirements.

 

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Why Asphalion?

With a strong track record of successfully executed projects for a wide range of products, including EU funded projects for development of highly complex and innovative technologies, Asphalion has gained key expertise in different technological areas and key regulatory areas.

In addition, Asphalion is strongly committed with digital transformation, which drives our team to provide expert support in development of digital solutions as medical devices. Furthermore, Asphalion is part of different MedTech clusters, which allows us to be at the forefront of digital innovation in the healthcare arena.

Main benefits

  • Medical Device specialized expertise
  • Time to market optimization
  • Minimization of commercial risks by anticipating and managing potential regulatory barriers
Talyta Carteano - Asphalion
Talyta Carteano
MedTech Director | Lead Auditor
“Asphalion offers a complete portfolio of Medical Device solutions, based on our 15+ years of expertise in the area.

We can adapt to each and all of our client’s needs with total flexibility for a tailor-made approach, always striving to meet the highest quality standards”

Related Resources

EU Authorised Representative Medtech

As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD

Flyer EUDAMED Asphalion

EUDAMED

Asphalion provides dedicated services for all EUDAMED related activities with an
impact on manufacturers of medical devices

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