Medical Devices

Our team of Medical Device 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

Medical Devices

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.

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.

Medical Devices 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

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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
Medical Device 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”

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