Together for better patient outcomes

Medical Devices

Medical devices play a key role in healthcare, vital for diagnosis, screening, monitoring, rehabilitation, treatment and care. With technological advancements, medical devices are drastically improving the efficiency and quality of health care.

Medical devices range from multi-therapies like simple tongue depressors and bedpans to complex programmable pacemakers and closed loop artificial pancreas systems. Based on the intended medical purpose, even software can also be considered as a medical device.

Medical Devices in multi-therapeutic areas

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Orthopedics
Cardiovascular
medical writing for medical devices
Diabetes
pharmacovigilance for medical devices
Nephrology
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Opthalmology
eu medical device regulations
Oncology
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Respiratory
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Nephrology

Key Regulatory Requirements for Medical Devices

US Medical Device Regulations

21 CFR Part 803 contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA

More about Post-Brexit Medical Device Regulations
EU Medical Device Regulations

In the EU, the Medical Device Regulation (EU) 2017 /745 (EU MDR) came into force on 25 May 2017 repealing the existing Medical Device Directive 93/42/EEC (EU MDD) with transition period of four years including end of extension period in May 2021.

More about Post-Brexit Medical Device Regulations
Post-Brexit Medical Device Regulations

Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, Where the single market relies on one set of rules, different rules will apply for different markets – newly defined in the EU and UK as of January 1, 2020.

More about Post-Brexit Medical Device Regulations

Key Regulatory Requirements for Medical Devices

The medical device companies need to have robust and effective strategies in place to ensure continued adherence to dynamic regulatory compliance and keep pace with increasing complexity within scientific elements of this area

The processes necessary to ensure compliance are complex and associated implementation activities could be challenging for small and medium organizations

  • Intake of device complaints
  • Intake and response to inquiries related to the medical device(s)
  • Triage and flag safety reports to the safety department

End to end safety data management during clinical trials and post marketing

  • Serious adverse events (SAEs)
  • Unanticipated serious adverse device effects (USADEs)
  • Unanticipated adverse device effects (UADEs)
  • Adverse events of special interest (AESI)
  • Device deficiencies
  • IDE reports
  • Annual safety reports
  • Literature monitoring
  • Trend analysis, signal detection
  • Electronic Medical Device Reporting (e-MDR)/ EUDAMED
  • Person Responsible for Regulatory Compliance (PRRC) as per the EU-MDR
  • Authorized Representative
  • Regulatory strategy design e.g., Medical device classification
  • Regulatory Submissions (e.g., Technical Files/Design Dossiers, CER for CE Marking etc.)
  • Expedited and periodic submissions to regulatory authorities
  • Technical Documentation & Quality management systems
  • Benefit-Risk Analysis and Risk Management
  • Post market surveillance (PMS) plan, Clinical Evaluation and Post market clinical follow up (PMCF) plan and protocols, PMCF reports etc.
  • Post market surveillance Report (PMSR)/ (Periodic Safety Update Report) PSUR
FAQs about IVD and IVDR

The APCER Advantage

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Domain Expertise
  • 100+ physicians, 90% healthcare professionals supporting drug safety and Pharmacovigilance
  • Experience and expertise in different product types including Drugs, Vaccines, Biologics, Biosimilars, Cell and Gene Therapy products / Advanced Therapy Medicinal Products, Medical Devices, and Combination products
  • Medical and scientific writing to support global product approval and post marketing requirements
pharmacovigilance services
Client Focus
  • Scalable and flexible operating models
  • Strong governance with collaborative approach
  • Outcome-driven engagements
  • End-to-end Pharmacovigilance, Medical Information, Regulatory Affairs, Quality Assurance and Medical Writing activities throughout the Product lifecycle
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Global Presence
  • Presence in US, UK, Europe, and Asia
  • Safety reporting capabilities in 100+ countries
  • Medical Information coverage in 50+ countries and 30+ languages, scalable to 100+ languages
  • Developing and contributing to regulatory strategies, to maintain global regulatory compliance across the product life cycle
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Quality and Compliance
  • Extensive experience in supporting successful Regulatory Inspections
  • ISO accreditations received:
    • ISO 9001:2015 (QMS)
    • ISO 27001:2013 (ISMS)
    • ISO 27701:2019 (PIMS)

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Testimonials

  • Medical Director
    APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

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