We have highly experienced medical device regulatory consultants in both Europe and the USA, who have led many regulatory filings, often liaising directly with the regulatory authorities on the client’s behalf. In Europe we can undertake filings under both the MDR and UKCA.

EARLY STAGE

we are at your side to support and consider you in the most critical early stages

  • Consultancy on the national, European and extra-European legislation (for specific countries)
  • Strategy consultancy and feasibility check on the company project, with indication of: product regulatory frame, classification, requirements to be complied with, costs
  • Due diligence and control of the compliance of the product technical documentation with the requirements of the applicable national and European regulations
  • Gap analysis on the documentation available to the Customer and on the company status in respect of Regulations 745/2017 and 746/2017
  • Assistance on environmental labelling for the packaging in Italy
  • Taking on the role of Regulatory Compliance Responsible Person

CE MARKING

New product on the market

  • Contacts with Notified Bodies to obtain the CE marking
  • Contacts with qualified laboratories to carry out tests on devices
  • Drafting/review/update of product technical dossiers in order to obtain/maintain/renew the CE certificates
  • Drafting/review/update of bibliographic clinical assessments
  • Drafting/review/update of risk analyses documentation
  • Control/review of labels and use instructions/handbooks
  • Assistance with the Notified Body until the CE marking is obtained and for the maintenance of the certification
  • Registration of manufacturers and MD and IVD notification to the Ministry of Health and to the Competent Authorities of other EU Member States
  • Acting as European Representatives

CLINICAL EVALUATION

Medical device CERs, CEPs, literature reviews & data analysis by clinically-active medical experts

  1. Clinical Evaluation Reports (CERs) & Clinical Evaluation Plans (CEPs) produced by MDR-trained medical writers.
  2. Systematic literature reviews & data analysis forming the core of compliant Clinical Evaluation.
  3. Ongoing Notified Body engagement support to address any queries and feedback after CER submission.
  4. Adherence to MDR standards for all device classes according to MDR Annex XIV, MEDDEV & MDCG Guidelines.
  5. Collaborative proposals with transparent, fixed-cost pricing to reflect the unique needs of your medical device

MEDICAL WRITING

Writing technical documents for medical device regulatory compliance is a skilled task that requires a wide range of skills.

  1. PMCF Plans, Study Protocols, Evaluation Reports, Investigator’s Brochures, ICFs & PILs to support your PMCF system.
  2. CERs & CEPs written by medical experts and comply with the latest guidelines & MDR Annex XIV Part A.
  3. Expert clinical evidence & systematic literature reviews for Clinical Evaluation, Gap Analysis and market access activities.
  4. Tailored technical documents meeting MDR requirements for specialist SaMD applications

CLINICAL EVIDENCE

An effective PMCF (Post-Market Clinical Follow-up) system is essential for ongoing approval of most medical devices under the EU MDR.

  1. PMCF study / survey design and implementation, fully compliant with EU MDR requirements.
  2. GDPR-compliant data collection and secure storage using online eCRF & ePRO systems, enabling real-time data input from any device.
  3. Lifetime monitoring of device usage with automated clinical data generation & reporting used for Clinical Evaluation and other areas of your MDR strategy.
  4. Ongoing PMCF system maintenance with adaptive clinical investigator management.
  5. Medical document writing including PMCF plans & reports, study protocols & evaluation reports, investigator’s brochures, ICFs & PILs.
2022-10-19T08:33:21+00:00

FULL SERVICES CRO

ACCELERATE YOUR CLINICAL DEVELOPMENT PROGRAM WITH CROlife Services include project management through to clinical trial monitoring, management and patient recruitment. CROlife has established relationships with trial sites, key [...]

2022-10-20T06:49:27+00:00

PHARMACO VIGILANCE

We manage post-marketing Pharmacovigilance activities for pharmaceutical companies that need complete and timely outsourced services to implement and maintain a pharmacovigilance system in accordance with the current legislation. EU [...]