Asphalion 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

Asphalion 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:

Support in Development

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

Support for CE certification & CE maintenance

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

Support in definition and implementation of QMS

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

Person Responsible for Regulatory Compliance (PRRC)

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.

European Authorized Representative (EU-AR) for Medical Devices and IVDs

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

UK Responsible Person

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

Responsiveness to any request and/or inspection from MHRA
Support for the Registration of Medical Devices with the MHRA
Regulatory Intelligence to monitor any change in local legislation
Management of incidents and/or complaints
Notification of incidents and/or complaints to MHRA
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.

US Agent

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:

Assistance with FDA registration and listing requirements
Expert guidance on US regulations and compliance requirements
Support for post-market reporting obligations, including adverse events, corrections, and removals
Coordination with FDA on behalf of the foreign manufacturer
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.

Internal Audits

Internal Audits: ISO 13485 conformity assessment Elevate Medical Quality with ISO 13485 excellence

What are the benefits of working with a quality system under ISO 13485?

Allows the certification CE Marking of medical devices under Medical Device Regulation (EU) 2017/745, It is not a mandatory requirement but it makes it easier to achieve.
High credibility of your company: Prioritizing patient safety, the certification ensures the implementation of effective risk prevention strategies. Following ISO 13485:2016 product requirements, you minimize the possibility of reputational damage due to solution shortcomings.
Great competitive advantage: By meeting ISO requirements, companies striving to advance in the fast-growing healthcare industry can reach more users. Having a product development process based on ISO 13485:2016 equals matching high industry standards of quality and gaining a strong position in the market.
Increased customer satisfaction: In addition to enhanced safety and quality, ISO 13485:2016 focuses on customer satisfaction. From product design to software & hardware development, companies that follow ISO standard put the end-user goals first. Given that medical devices directly affect patients’ well-being, a focus on customers becomes vital. Your customers must be certain that you deliver on the intended purpose.
Protection against legal proceedings: Authorities are especially strict when it comes to healthcare regulations. The healthcare sphere is not about second chances, and government bodies need evidence of your complete dedication and conformity to specific standards. By incorporating ISO 13485:2016 requirements into your medical solution, you meet other regulations and fit within the medical products allowed on the market.

To whom does the ISO 13485 standard apply?

This standard applies to manufacturers, distributors, importers and Authorized representatives of medical devices, and also to sterilization services for medical devices and technical assistance and maintenance services.

Why is it necessary to carry out internal audits of the quality system under ISO 13485?

Regulatory Compliance: Conducting conformity assessment ensures that a company´s QMS aligns with these regulatory requirements.
Product Quality: Implementing and assessing conformity to these standards enhances product quality, leading to greater customer satisfaction, fewer product recalls, and improved brans reputation.
Legal and Liability Protection: ISO 13485 Conformity Assessment is vital for medical device companies to meet regulatory requirements, ensure patient safety, maintain product quality, manage risks, access global markets, foster improvement, and protect against legal and liability issues.

How the audit process is carried out:

Audit requirements _ Audit Plan: Firstly, an audit plan is carried out under ISO 13485, to take into account all the points regulated by the standard.
Collection of evidence and evaluation_ Audit activities: Subsequently, the activities of meetings with the company are carried out, evidence is collected according to the audit plan and it is evaluated whether the evidence collected is in accordance.
Audit findings_ Audit report: As a last step, non-conformities are described according to categories and points to improve in an audit report. Such nonconformities must be resolved by the company.

What were the top 5 non-conformities as presented:

Number 1 – ISO 13485 Clause 7.1 – Planning of product realization including risk management

- Issue #1: Records of risk management not updated during life cycle of product.
- Issue #2: PMS data not feeding into Risk Management & Clinical Evaluation.
- Issue #3: Risk management process not aligned to ISO 14971:2019, including applicable Annex (e.g. ZA/ZB for EU Regs).
- Issue #4: No risk management process in place.

Key takeaway: Must ensure that you establish robust links to change management, PMS, and design inputs.

Number 2 – ISO 13485 Clause 8.2.4 – Internal audit

- Issue #1: Records of internal audits not complete (reports, plans, CAPAs).
- Issue #2: Risk-based approach not applied to planning of audits or Internal audit schedule not maintained.
- Issue #3: No timely follow-up of actions resulting from internal audits.
- Issue #4: No records of internal auditor competence to applicable regulation(s).
- Issue #5: Internal auditor not impartial.

Key takeaway: Must ensure that you can show evidence of a risk-based approach to internal audits, covering regulatory requirements, by trained auditors, and with timely follow-up.

Number 3 – ISO 13485 Clause 7.5.6 – Validation of processes for production and service provision

- Issue #1: Records of process validation and production software validation not maintained.
- Issue #2: Re-validation process not defined.
- Issue #3: Not utilizing a risk-based approach or defining statistical techniques/sample size rationales in validation activities.
- Issue #4: No demonstrable links to change management process.
- Issue #5: Equipment qualification records not held (especially installation and operational qualification for new equipment).

Key takeaway: Must ensure that you can demonstrate robust process links to change and risk management processes.

Number 4 – ISO 13485 Clause 8.2.6 – Monitoring and measurement of product

- Issue #1: Test/verification records not maintained.
- Issue #2: Acceptance criteria not defined or not aligned with design specification.
- Issue #3: Traceability to individuals performing tests.
- Issue #4: Monitoring and measuring of product process not defined & no demonstrable link to non-conforming product process.

Key takeaway: Must ensure that you have adequate monitoring and measuring for product conformity during manufacture and its conformity to design specification.

Number 5 – ISO 13485 Clause 7.5.1 – Control of production and service provision

- Issue #1: Incomplete or insufficiently completed batch release/production records.
- Issue #2: Inadequate monitoring and measuring during manufacturing process.
- Issue #3: No records of qualification of infrastructure.
- Issue #4: Insufficient documentation to ensure product conformity to specification.

Key takeaway: Must ensure that you can show sufficient control and records to demonstrate conformity to specification.

Reasons to outsource internal audits with Asphalion:

High Experience in Medical Devices
Highly qualified personnel
Independence of the company
Confidentiality
Cost optimization
Helps with the continuous improvement of the company.

⬇️ Download here our Internal Audits flyer for more information

Clinical Evaluation Reports (CERS)

Navigating Clinical Evaluation Under MDR 2017/745: A Deep Dive into Structures, Routes, and Regulations

Introduction:

The introduction of Medical Device Regulation (EU) 2017/745 revolutionizes the approach to medical device legislation in the EU, significantly enhancing the requirements for clinical evaluations. This article explicates all you need to understand about Clinical Evaluation, the routes for different device types, and the essential standards and guidelines impacting these evaluations.
The final goal of medical device clinical evaluation is to establish and maintain proof that medical devices are safe for use and achieve intended performance throughout their expected lifespan.
Clinical evaluation shall consist of a continuous assessment process integral to the company’s quality management system, conducted by qualified personnel. Ensures medical devices meet regulations and standards from initial conception through post-market feedback.

Detailed Overview of CER Structure

A Clinical Evaluation Report (CER) is fundamental to the MDR’s demand for detailed evidence of device efficacy and safety. Below is a comprehensive break-down of its typical structure:

Scope of the Clinical Evaluation: Establishes the breadth and purpose of the evaluation.
Clinical Background, Current Knowledge, State of the Art: Analysis of existing medical and device-specific data.
Device Under Evaluation:
1. Type of evaluation
2. Demonstration of equivalence (if claimed)
3. Clinical data generated and held by the manufacturer
4. Clinical data from literature
5. Summary and appraisal of clinical data
6. Criteria for performance
7. Criteria for acceptability of side effects
Conclusions: Insights and implications derived from the evaluation.
Date of the Next Evaluation: Scheduled timing for subsequent review.
Dates and Signatures: Document authentication by relevant personnel.
Qualification of the Responsible Evaluations: Expertise and credentialing of evaluators.
References: Bibliographic references supporting the evaluation.

Clinical Evaluation Routes and Device-Specific Considerations

Standards and Guidelines

Confronting Challenges and Outsourcing Rationale

Common challenges faced by manufacturers:
- Identifying the appropriate clinical evaluation route.
- Generating and documenting sufficient clinical evidence.
- Maintaining consistency across all necessary documentation including the CER, Clinical Evaluation Plan (CEP), Instructions for Use (IFU), risk management files, and post-market surveillance data.
Frequent reasons behind the outsourcing of CER preparation
- Lack of internal expertise.
- Cost-effectiveness.
- Resource limitations.

Conclusion:

While MDR 2017/745 sets high standards for medical device regulation, a comprehensive understanding and application of the detailed structures and guidelines provided is crucial for achieving compliance.

Clinical evaluation, coupled with risk management, serves as the cornerstone of regulatory compliance for medical devices.

These elements are the focus of the most thorough scrutiny by notified bodies to ensure that devices meet relevant general safety and performance requirements before they reach the market.

Keeping abreast of these requirements and faithfully implementing them are key to successful device approval and continued market presence in the EU. By staying well-informed and vigilant in these areas, manufacturers can navigate the regulatory landscape more effectively and ensure ongoing compliance and safety of their products.

⬇️ Download here our CERS flyer for more information

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Why Asphalion MedTech?

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

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

FLYER | Additional National Procedures for Medical Devices (AEMPS)

Additional National Procedures for Medical Devices in the Spanish Market

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Navigate FDA Requirements with Confidence

FLYER | Design and Development for Medical Devices: Navigating ISO 13485

Design and Development (D&D) for Medical Devices

FLYER | FDA De Novo Authorization procedure

Overview ofthe De Novo Pathway

FLYER | Medical Device Software Standard IEC 62304:2006

Medical Device Software Standard IEC 62304:2006 /Amd 1:2015

FLYER | Regulation (EU) 2017/745: Understanding its impact on Drug-Device Combinations in Directive 2001/83/EC

Drug–device combination products (DDCs) and how are they classified in Europe

FLYER | EU Authorized Representative, UK Responsible Person and US Agent

When manufacturers of medical devices operate outside certain regulatory regions, they must appoint an official representative to ensure compliance with local laws and regulations.

FLYER | Understanding Usability: Definition and principles

By prioritizing usability, devices achieve their intended purpose while protecting patients and users.

FLYER | Risk Management ISO 14971

Risk Management for Medical Devices: Navigating ISO 14971:2019

FLYER | EU Authorized Representative, UK Responsible Person, US Agent

The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer, and provide a copy of the mandate to the competent authority, upon request.

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FLYER | A guide to demonstrate biocompatibility under Medical Device Regulation (EU) 2017/745

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Asphalion 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