The medical device industry is undergoing significant change in areas ranging from new and more-complex regulations to technology advances that are altering the medical-technology (medtech) landscape by changing it into an increasingly competitive and commoditized marketplace.

As a global leader in medtech specialized services, PharmaLex has the knowledge and experience to guide you through those challenges across all global markets, including North America, Europe and Asia Pacific.

As your global partner, PharmaLex supports the entire continuum of regulatory, quality and market strategy needs for every therapeutic area. We have extensive experience in all product classifications for:

SMARTCHECK MDR

SMARTCHECK MDR assesses a company’s readiness for the EU Medical Device Regulation effective May 2021.

By completing just five questions of SMARTCHECK MDR we can help you determine your state of compliance.

SMARTMDR

Digital Health

Are you developing health-related software or smart apps? Do you know if your software or app will be classified as a medical device? And is your product ready to meet the requirements of the EU Medical Device Regulation (MDR) effective May 2021?

Digital Health MedTech Services PharmaLex

Whether your market ambitions are local or global, we are with you at every step of the journey

  • Strategic guidance
  • Product development and Program Management
  • Quality Management Systems set-up
  • Regulatory submissions
  • Post market compliance
  • Health economics.

Our commercial services include:

  • Due diligence
  • Supplier management

We partner with companies in every phase of development through to commercialization across the life sciences sectors, leveraging our experts’ market and medtech knowledge to help you achieve your goals.

From start-ups to top 10 multi-nationals, we partner with companies of every size across the medtech sectors, delivering robust, region-specific services for market success.

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  • European Union medical device regulation (EU MDR) and in vitro diagnostic regulation (IVDR).

EU MDR and IVDR

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices were officially published on May 5, 2017, and came into force on May 25, 2017. Implementation and ongoing compliance with the MDR and IVDR present significant challenges for medical device manufacturers, which sometimes have had no experience in dealing with such stringent requirements. PharmaLex’s dedicated MedTech Services team offers the breadth and depth of expertise necessary to support you throughout a product’s lifecycle. We apply proven methodologies and offer hands-on support to optimize and customize quality and regulatory solutions that get delivered on time, within budget and with the highest quality. Our professional and experienced medical device team provides seamless support to keep you compliant — and moving forward.

Our MDR/IDVR compliance services include:

To achieve compliance, medical device manufacturers must assess gaps in their technical documentation and processes against the requirements of the new regulations. The PharmaLex MedTech team performs thorough gap assessments and provides analysis and advice on remediations of gaps.

The MDR and IVDR introduced new and more-complex classification rules that can be difficult to deal with and that raise questions and cause confusion for manufacturers. We prepare product classification reviews and reports to ensure your product gets classified accurately. In borderline areas or in cases of disagreement, we support you with notified-body discussions around device classification.

The MDR and IVDR require a number of changes to be made to the quality management system, many of which must be implemented by the date of application rather than when a device gets transitioned to the appropriate regulation. PharmaLex MedTech supports you through that process by handling preparations for notified-body inspections as well as other regular inspections such as supplier audits. We can also support economic operators — such as authorized representatives, importers and distributors — in updating their quality management systems to ensure that the systems meet the new MDR and IVDR requirements, and we can help with implementation if required.

The MDR and IVDR contain additional emphasis on clinical data requirements as well as new equivalence rules. Our medical writers are experienced in managing updates to clinical evaluation and performance evaluation plans and reports to ensure compliance. In a case in which additional clinical data may be required, we help you determine the appropriate clinical strategy, and we offer support with the design and set-up of the clinical trial, including obtaining all of the necessary approvals.

A number of changes are needed to technical documentation as a result of the MDR and IVDR. We help you achieve compliance whether you need (1) updates made to a single document, (2) guidance regarding the implementation of new elements or (3) management of the full transition of documentation to the new regulations.

Examples of the support we can provide are as follows.

  • Technical documentation preparation and management, including general safety and performance requirements
  • Instructions for use and labeling updates and review
  • Creation of a Unique Device Identification (UDI) system, including basic UDI-DI
  • Post market surveillance
    • Creation of post market surveillance plans and post market clinical-follow-up plans
    • Vigilance reporting
    • Summary of safety and clinical performance (SSCP)
    • Creation of periodic safety update report (PSUR) and post market surveillance report (PMSR).

If your notified body does not obtain designation under the new regulations, we can help you identify and select suitable alternative notified bodies.

Our medical device team can train your employees either on the overall regulations or in specific focus areas.

Services At A Glance

A successful regulatory strategy demands a commercial approach that targets the broadest, most-competitive product attributes and that is aligned with the development science and clinical positioning.

We work with you to confirm regulatory requirements and define the pathways to regulatory approvals and reimbursement. PharmaLex’s extensive experience with regulatory preconsultations removes the unknowns and reduces project risk.

By means of its global expertise, PharmaLex understands the importance of a well-developed strategy that targets the prime markets and then leverages initial approvals to support accelerated secondary-market access.

Even in an era of harmonization, local regulations vary widely, and we address those local differences by building comprehensive understandings of technical requirements and standards and matching them to the various regulatory processes.

PharmaLex MedTech Services helps you build a core data set in harmonized technical files to support multiple international filings.

We work with you to ensure your development processes generate technical data that meet regulators’ rigorous expectations.

Our team consists of experts in the areas of:

  • Biocompatibility
  • Preclinical testing
  • Clinical validation
  • Electrical safety
  • Software validation
  • Manufacturing
  • Labeling and marketing
  • Laboratory analysis and more

From registration application preparation, submission and management through to approval, regulatory problem solving and administrative appeals, PharmaLex MedTech works alongside you as an integral part of your team — every step of the way.

Our aim is to help you prepare complete and accurate technical files and regulatory dossiers. We specialize in risk assessments, the design history file (a US Food and Drug Administration [FDA] requirement), clinical evaluation reports and more.

PharmaLex MedTech provides global clinical development and clinical regulatory expertise to support you at every step of the clinical development pathway — from first-in-human studies through registration.

Investigational Device Exemption Applications
Our team supports companies through the entire process leading to investigational device exemption (IDEs). We support pre-IDE meetings and consolidation of submission packages for institutional review boards, ethics review boards, regulators and competent authorities throughout the world.

Good Clinical Practice Support
We provide comprehensive good clinical practice support, including investigational-site training, auditing and remediation support.

Clinical Development and Clinical Strategy Consulting
Given our expert understanding of the clinical, regulatory and competitive landscapes, PharmaLex is ideally positioned to offer smart strategies and skillful tactics for device and diagnostic-product development across the entire therapeutic spectrum. Our expert statistical analysis team provides support with designs of streamlined yet powerful statistical analysis plans.

Clinical Monitoring
Our global network provides the capabilities needed for support in the area of clinical-trials monitoring.

Clinical Program Management
We provide program management for clinical trials and act as clinical trial manager for organizations in all major regions worldwide.

Post market compliance is built on a foundation of comprehensive and continuing client-focused product feedback, monitoring and proactive regulatory reporting. Robust systems and processes are essential, and PharmaLex MedTech can help build them and train your team. In addition, we support you in the management of emerging issues with a view to minimize disruption to your business.

Our team also supports post market reporting and can serve as an outsourced reporting team or adviser. We analyze reporting trends and review reporting requirements to ensure you achieve the proper balance with a specific regulator or group or regulators in scope.

With enhanced regulatory requirements comes a heightened need for medical-writing expertise. Our team stays abreast of the latest regulatory changes as well as all related clinical evidence, including clinical-evidence reports, performance evaluation reports, literature reviews, post market surveillance reports and clinical summaries.

Leverage the experience and technical expertise of our team to generate comprehensive reports that demonstrate thorough and consistent evaluation of your product.

EU MDR Post Market Surveillance Requirements

We have a benchmarked approach to the upgrading of post market surveillance requirements to ensure you have proper clinical-evaluation-report plans, post market clinical follow-up and compliance with EUDAMED (European Database on Medical Devices).

EU IVDR Post Market Surveillance Requirements

Our team has extensive experience in transitioning previously exempt IVDs to regulated systems, upclassified IVDs, and new entrants to the European Market.

Clinical Evaluation Reports and Performance Evaluation Reports

We provide the services of authoring, reviewing and consulting to ensure your clinical evaluation reports and performance evaluation reports meet local requirements, including those of the EU MDR, Australia’s Therapeutic Goods Administration and China’s National Medical Products Administration. We offer routine update services that give you the assurance that the clinical evidence supporting your registrations is being consistently and proactively managed.

The medical device market is both complex and rapidly changing, yet also offers huge opportunity for progressive businesses. PharmaLex Medtech provides due diligence services to companies seeking to diversify their portfolios, and to investment/business consulting firms seeking to understand the highly regulated/technical challenges and opportunities of new medical device or diagnostic ventures. These services range from provision of insight into the regulatory and commercialization environment and predictions as to overall market trends, through to determination of the technical and commercialization challenges for early phase development.

Quality systems are all about the rigor and discipline needed to ensure continuous improvement, compliance and product consistency.
PharmaLex MedTech can ensure that your employees and partners adhere to requirements by means of a global quality management system and can also advise on special-purpose quality management systems for clinical laboratories, R&D facilities or design houses.

Our medical device quality management system expertise helps you follow best practices, adhere to global compliance requirements and adopt a streamlined, consistent approach to managing the system. Whether for ISO 13485 or the FDA’s Medical Device Single Audit Program or 21 CFR 820 FDA QSR compliance, our team can support any medical device or diagnostic project need.

Inspection Readiness

  • Avoid panic or surprises or scrambling to prepare
  • Let us assist you with your readiness

Preparation makes the difference. Follow the 8Ps!

We can assist throughout the eights steps of preparedness as follows.

  1. PURPOSE – Clear and communicated by top management
  2. PEOPLE – Defining and taking ownership and accountability
  3. PROCESS – Compliant, effective and efficient
  4. PRODUCT – Safe, effective and meets client’s needs
  5. PHYSICAL ENVIRONMENT – Organized, clean and in control
  6. PLANNING AHEAD – Ready at all times for inspection; audit logistics defined and in place
  7. PROGRESS – Quality metrics and analysis
  8. PRACTICE  PRACTICE  PRACTICE – Mock inspections and audits.

Internal Audits and Preaudit Support

Comprehensive multi-site and multi-scope audit services, including areas for improvement

Preaudit Support

Support to prepare for audits as well as during an audit

Supplier Audits

Virtual or in-person supplier audits throughout the world

Attendance at Regulatory Audits and Observation Resolutions

In most jurisdictions, regulatory agencies insist that a product license be held by a legal entity domiciled within the market — typically, a registered company. The local entity is usually known as a marketing authorization holder, authorized representative or sponsor. The entity takes responsibility for the product on the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer, and therefore, the selection of representative or license holder is critical to the orderly continuation of supply.

PharmaLex MedTech provides authorized-representative services in multiple markets. This is more than an administrative solution: we take charge of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.

As a specialist market representative, we take responsibility for regulatory compliance and provide the interface with regulatory authorities. This gives you the peace of mind that your regulatory compliance is being managed professionally. And it ensures that distribution arrangements are independently structured for maximum commercial benefit.

In most jurisdictions, regulatory agencies insist that a product license be held by a legal entity domiciled within the market — typically, a registered company. The local entity is usually known as a marketing authorization holder, authorized representative or sponsor. The entity takes responsibility for the product on the market, files regulatory submissions and conducts communications with the regulator on behalf of the manufacturer, and therefore, the selection of representative or license holder is critical to the orderly continuation of supply.

PharmaLex MedTech provides authorized-representative services in multiple markets. This is more than an administrative solution: we take charge of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.

As a specialist market representative, we take responsibility for regulatory compliance and provide the interface with regulatory authorities. This gives you the peace of mind that your regulatory compliance is being managed professionally. And it ensures that distribution arrangements are independently structured for maximum commercial benefit.

Biocompatibility

PharmaLex MedTech biocompatibility experts bring decades of experience in the biological evaluation of medical devices and combination products. As accredited experts to ISO in the preparation of the ISO 10993 biocompatibility standards (as well as the ISO 22442 series on biological origin materials and ISO 18562 biocompatibility of respiratory gas pathways), PharmaLex’s experts provide the highest levels of knowledge and expertise. Our long-standing, active participation ensures our clients are supported with new revisions to the standards as well as with the support needed to comply with requirements globally.

Success in biocompatibility involves understanding not only the science of the requirements but also how the requirements are interpreted by different regulators. We have extensive experience in the area of regulatory application of biocompatibility. It includes direct negotiations with regulators in North America, Europe and Asia Pacific for testing strategies and the use of risk assessments to improve processes and speed up evaluations.

Our experience covers a broad range of devices and materials as well as different local interpretations of regulations.

Whatever your biocompatibility needs, we will work with you every step of the way.

Our experts can support:

  • Toxicological or Biocompatibility Risk Assessment
  • Biocompatibility Strategy
    Including presubmission consultations with regulators
  • Preclinical Testing Plans
    Including the design of large-animal preclinical functional studies for devices
  • Preclinical Program Management
    End-to-end program management, including opening tenders and selecting and working with laboratories and other suppliers and service providers
  • Result Evaluation, Chemical Characterization
    With the evolving requirements around risk analysis to determine the testing plan, we provide an experienced perspective on evaluations of results and incorporations of chemical characterization results and findings to the biological testing.
  • Preparation of Complete Biological Evaluation Reports

IVD/Diagnostics Specialized Services

We have a record in IVDs that is second to none. Whether it involves a multi-gene assay from a next-generation sequencer, a companion diagnostic, artificial intelligence for automated pathology image analysis, traditional laboratory ELISA or point-of-care rapid tests, we have the global experience necessary to support you in the areas of:

  • Artificial intelligenceCompanion diagnostics
  • Genomics and proteomics
  • Home-use tests
  • Molecular diagnostics
  • Laboratory tests
  • Point-of-care rapid tests
  • Software as a medical device.

Our comprehensive diagnostic capabilities covers all types of biomarkers such as:

  • DNA
  • RNA
  • Protein
  • Cell
  • Tissue
The Ins and Outs of Outsourcing

Combination Products and Companion Diagnostics

As a leader in the field of specialized life sciences services, we have the know-hows to coordinate combination products and companion diagnostic product registrations and to support them throughout the entire registration lifecycle.

Because our organization has both pharmaceutical and medical technology expertise, we can manage the intricacies of borderline products and navigate unique regulatory pathways for them in all major markets.

Combination Products

Our comprehensive approach means we can support combination products that have primary modes of action as either devices or pharmaceutical products.

Companion Diagnostics

We have thorough familiarity with and are experienced in navigation of the complexities of supporting companion diagnostics through pharmaceutical clinical trials and subsequent registrations.

Global Reach. Local Presence.

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MDR Readiness

SMARTCHECK MDR is a highly effective tool that PharmaLex developed to assist medical device manufacturers in assessing the MDR readiness of their medical devices and quality management systems.

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