Regulatory services

1MED provides full regulatory support services to guide your Company in the pre-market and post-market phases

The medical device regulations are becoming increasingly difficult, making it harder to deal with the changed and updated requirements for compliance.

1MED is aware of the fact that a well-designed regulatory strategy has to consider not only European and International regulations, but also development costs, development cycles and profitability concerns.
We translate medical device regulations into concrete regulatory strategies for your specific project, providing a customized and dedicated successful and thorough support.

 We are a multi-disciplinary team

1MED regulatory team has proven expertise in all phases of product development and has a high degree of specialization in many medical fields.

 We offer turn-key services

We support our clients through all stages of a product’s lifecycle, from preclinical assessment to pre-market clinical trials, all the way to CE marking and post-market surveillance activities.

 We ensure regulatory compliance

1MED team participates in International Regulatory Technical Committees to always be “up to date” with incoming and new regulatory requirements. We therefore adapt our approach and documentation accordingly in order to always ensure compliance to current requirements.

 We have a customized and problem-solving approach

In 1MED we work side-by-side with our clients in designing and implementing a competitive and cost-effective regulatory strategy. We together tailor the proper pathway in order to fit each clients’ needs for reaching the desired timelines and maintain budgeted costs, still complying with regulatory requirements and also anticipating potential regulatory issues.
We support clients in the liaison with NBs and CAs
We prepare and submit reviewers-friendly technical documentation, helping clients to go through the interaction processes with NBs or CAs quickly and effectively.
In 1MED we also assist our clients in negotiating with national and international Notified Bodies, FDA and international regulatory agencies.

We can support you for the following activities:

  • Gap analysis for compliance with new Regulation 2017/745 on Medical Devices (MDR) and new Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR)
  • Regulatory strategy for CE mark: medical device classification, identification of applicable requirements, technical standards, preclinical and clinical studies for CE marking according to MDR
  • Regulatory strategy for FDA approval, FDA applications for pre-IND, IND, IDE, 510(k) and PMA.
  • Notified Body selection
  • Technical documentation preparation and maintenance (Technical File/Design Dossier, e-TF) MDR-compliant
  • Product’s leaflet and labels texts preparation and review
  • Scientific Literature Review
  • Clinical Evaluation File according to MEDDEV 2.7.1 Current Edition and MDR
  • Post Market Surveillance (PMS)
  • Post Market Clinical Follow-up (PMCF)
  • Post Market Vigilance (PMV)
  • Support to Company’s Risk Management Team for medical device risk analysis according to ISO 14971
  • Support for Biological Evaluation for biocompatibility tests planning
  • Support in the completion of Design History File (DHF) and Device Master Record (DMR)
  • CTD for drug substance and drug product for combination products (drug-device)
  • Interaction with Notified Bodies and Competent Authorities during certification processes
  • Food supplements and medical devices worldwide registration and registration maintenance (Europe, North Africa, Middle-East, South-America, Australia, Hong-Kong, Singapore, Russia and many others) 
  • Cosmetic Product Information File (PIF)
  • Training (regulatory and quality)

Regulatory services

1MED provides full regulatory support services to guide your Company in the pre-market and post-market phases

The medical device regulations are becoming increasingly difficult, making it harder to deal with the changed and updated requirements for compliance.

1MED is aware of the fact that a well-designed regulatory strategy has to consider not only European and International regulations, but also development costs, development cycles and profitability concerns.
We translate medical device regulations into concrete regulatory strategies for your specific project, providing a customized and dedicated successful and thorough support.

 We are a multi-disciplinary team

1MED regulatory team has proven expertise in all phases of product development and has a high degree of specialization in many medical fields.

 We offer turn-key services

We support our clients through all stages of a product’s lifecycle, from preclinical assessment to pre-market clinical trials, all the way to CE marking and post-market surveillance activities.

 We ensure regulatory compliance

1MED team participates in International Regulatory Technical Committees to always be “up to date” with incoming and new regulatory requirements. We therefore adapt our approach and documentation accordingly in order to always ensure compliance to current requirements.

 We have a customized and problem-solving approach

In 1MED we work side-by-side with our clients in designing and implementing a competitive and cost-effective regulatory strategy. We together tailor the proper pathway in order to fit each clients’ needs for reaching the desired timelines and maintain budgeted costs, still complying with regulatory requirements and also anticipating potential regulatory issues.
We support clients in the liaison with NBs and CAs
We prepare and submit reviewers-friendly technical documentation, helping clients to go through the interaction processes with NBs or CAs quickly and effectively.
In 1MED we also assist our clients in negotiating with national and international Notified Bodies, FDA and international regulatory agencies.

We can support you for the following activities:

  • Gap analysis for compliance with new Regulation 2017/745 on Medical Devices (MDR) and new Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR)
  • Regulatory strategy for CE mark: medical device classification, identification of applicable requirements, technical standards, preclinical and clinical studies for CE marking according to MDR
  • Regulatory strategy for FDA approval, FDA applications for pre-IND, IND, IDE, 510(k) and PMA.
  • Notified Body selection
  • Technical documentation preparation and maintenance (Technical File/Design Dossier, e-TF) MDR-compliant
  • Product’s leaflet and labels texts preparation and review
  • Scientific Literature Review
  • Clinical Evaluation File according to MEDDEV 2.7.1 Current Edition and MDR
  • Post Market Surveillance (PMS)
  • Post Market Clinical Follow-up (PMCF)
  • Post Market Vigilance (PMV)
  • Support to Company’s Risk Management Team for medical device risk analysis according to ISO 14971
  • Support for Biological Evaluation for biocompatibility tests planning
  • Support in the completion of Design History File (DHF) and Device Master Record (DMR)
  • CTD for drug substance and drug product for combination products (drug-device)
  • Interaction with Notified Bodies and Competent Authorities during certification processes
  • Food supplements and medical devices worldwide registration and registration maintenance (Europe, North Africa, Middle-East, South-America, Australia, Hong-Kong, Singapore, Russia and many others)
  • Cosmetic Product Information File (PIF)
  • Training (regulatory and quality)

REGULATION (EU) 2017/745

REGULATION (EU) 2017/745