Services Provided By
Happy Scientifics Limited ®
Clinical/Medical Writing
Clinical Evaluation Report (CER) is one of the key changes after the
implementation of MDR where medical device manufacturers struggle to
cope with. We offer complete solution related to Clinical according to EU
MDR
• Clinical Strategy
• Preparation of Clinical Evaluation Plan
• Literature search, appraisal and literature analysis
• Compilation of Clinical Evaluation Report (CER)
• Communication with the notified body and query management
• Post Market Clinical Follow-up report
• Training for CER and PMCF
Regulatory Affairs
Training
- Clinical Evaluation Report writing with literature
search, appraisal and compilation - QMS: ISO 13485, ISO 9001, ICH Q10
- Post Market Clinical Follow-up report
- EU MDR/IVDR/MEDDEV
- Good Manufacturing Practice (GMP).
- Regulatory Requirements for global markets.
- Design Control.
- FDA registration process.
- Biocompatibility of medical devices to manage
biological risk: ISO 10993 - Tailored training to suit your organisation
Auditing
❑ QMS Audits: We conduct internal and external audits of our clients’
QMS to ensure compliance with regulatory requirements and identify
areas for improvement.
❑ Supplier audit: We provide guidance on managing suppliers and
ensuring that their quality systems meet the requirements of the
medical device industry.
❑ Internal Audit: …..
- QMS: ISO 13485, ISO 9001, ICH Q10
- EU MDR/IVDR/MEDDEV
- Pharmacovigilance: EU Volume 9b, PV/Adverse Events, Directive
2001/82/EC - MDSAP (Medical Device Single Audit Program)
- Supplier quality system
- GxP audits for the pharmaceutical, medical device and related
industries 21 CFR part 210/211, 820, part 58 (GLP), 21 CFR part
600 - Clinical Audit: Clinical Evaluation Report, Post Market Clinical
Follow-up, Clinical investigation ISO 14155, ICH GCP, ICH E6 / - Sterilization of health care products ISO 11135, ISO 11137
- Biocompatibility of medical devices to manage biological risk: ISO
10993 - Medical Device Software: ISO 62304, IEC 82304
- Medical device Risk Management: ISO 14971,
- Medical devices utilizing animal tissues and their derivatives: ISO
22442
MDR/IVDR Transition
We offer a comprehensive range of services to support the compliance of
medical device companies with the EU Medical Device Regulation (MDR)
and EU In Vitro Diagnostic Medical Device Regulation (IVDR). Our services
include:
- IVDR/MDR Gap Assessment: We conduct a thorough assessment of
your current regulatory compliance and identify the gap between your
current compliance status and the requirements of the IVDR / MDR. - Technical File Remediation: We assist in the development and updating
of your Technical Files to meet the requirements of the IVDR / MDR and
provide guidance on how to maintain them. - Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
Writing: We help in the preparation and review of CERs and PERs, which is
a key requirement of MDR and IVDR. - Scientific Validity Report writing: we help in the preparation and review
of SVR. - Notified Body Assessment: We provide guidance and support in the
selection of a Notified Body for IVD and assist in the preparation and
submission of the application for certification. - Training: We offer training on the IVDR / MDR and its requirements,
including the transition process and the new classification system, to
ensure that your team is prepared for the changes ahead.
Our team of experts has extensive experience in navigating the regulatory
requirements for IVD / MD and can provide the guidance and support
needed to ensure a successful transition to the IVDR / MDR. We work
closely with our clients to understand their unique needs and develop
customized solutions to support their success.
Templates and Tools
- Technical File
- General safety and performance requirements
- Performance Evaluation Plan & Report
- Analytical Performance Plan & Report
- Clinical Performance Plan & Report
- Scientific Validity Reports
a. Literature search and selection protocol
b. Literature selection tables
c. Literature search and selection report
d. Scientific Validity Report - Post-Market Surveillance (PMS)
a. Post-market Surveillance Plan
b. Post-market Surveillance Report
c. Periodic Safety Update Report
d. Post-market Performance Follow-up Plan
e. Post-market Performance Follow-up Evaluation Report
f. Summary of Safety and Performance - Risk Management System
a. Risk Management Plan
b. Risk Management Report
c. Risk Analysis FMEA Tables (incl. examples)
d. Risk Assessment Record
e. Roadmap to Risk Assessment
Quality Management
We offer a range of services to support the development and implementation of a Quality Management System (QMS) for medical device companies. Our services
include:
- QMS Development: We assist our clients in developing a QMS that meets the requirements of ISO 13485, MDR, IVDR and 21 CFR 820, as well as any other relevant international standards.
- QMS Audits: We conduct internal and external audits of our clients’ QMS to ensure compliance with regulatory requirements and identify areas for
improvement. - Supplier Quality Management: We provide guidance on managing suppliers and ensuring that their quality systems meet the requirements of the medical device industry.
- CAPA: We help our clients develop and implement a Corrective and Preventive Action (CAPA) system to address non-conformances and prevent recurrence.
- Risk Management: We assist our clients in identifying, evaluating, and
controlling the risks associated with their devices throughout the product
lifecycle. - Training: We offer training on various aspects of QMS, including ISO 13485, MDR, IVDR, 21 CFR 820, and other relevant international standards.
UK/EU Authorised Representatives/ Person Responsible for Regulatory Compliance (PRRC)
As your EU Authorised Representatives, our goal is to help you get your products ready to be sold. Our authorised representatives ensure that all of
your important technical documentation and your declaration of conformity is drawn up in the correct way, we also keep your documents at the
disposal of the market surveillance authorities for the required period. If your product proposes a risk, we can guide you in how to take the
necessary corrective action to rectify any issues, our representative services are in place to ensure full compliance.
As your UK authorised representatives, we help you get your products out in to the world by assuring you fully comply with all regulations and
directives in the UK. We make sure all of your UK Declaration of Conformity and technical documentation has been drawn up correctly and keep
them at the disposal of market surveillance authorities for the required period. If we identify any risk with your products, we can support you
through remedying any non-compliance.
Person Responsible for Regulatory Compliance (PRRC) is a requirement for medical device and IVD manufacturers and Authorised Representative:
article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) state that each manufacturer and authorised representative (if applicable)
must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.
Why do you need a EU Authorised Representative?
As the UK left the single market on the 1st January 2021, UK based manufacturers or manufacturers outside EU who were selling through a
distributor into the EU must have an EU-based Importer or alternative representation. The Government is advising that their distributor becomes
their importer however, if this is not possible or desirable, they can appoint someone else to carry out the Importer obligations for them.
EU law ceased to apply within the UK on 31 December 2021 (although Northern Ireland remains within the Single Market and so is effectively
still part of the EU for the purposes of product safety legislation). This means that manufacturers based outside the UK wishing to sell within the UK, including those based in the remaining EU27 countries, must have representation within the UK. Regulation (EU) 2019/1020 came into force on the 16th July 2021 and requires one of the following economic operators – Importer, Authorised Representative (AR) or Fulfilment service provider – to be located in the EU and their details presented with the product. The Regulation makes it illegal to place certain products on the EU market unless a responsible EU-based economic operator is established. Manufacturers that currently sell, or offer to sell, directly to end users (both professional and consumer) in the EU, without an EU-based economic operator being involved, must appoint one before placing further products on the EU market.
Regulation
(EU) 2019/1020 came into force in the EU and Northern Ireland on the 16th July 2021. The UK has said it is not going to implement the
Regulation so it will not apply in Great Britain (England, Wales and Scotland). Instead a market surveillance framework based on the New Legislative
Framework (NLF) Regulation EC 765/2008 will continue to apply. The government will bring forward clarifying legislation ‘in due course’. The NLF
framework requires importers responsible for placing goods on the GB market to be identified on the product, its associated documentation or the
packaging. Importers are also required to ensure that the UKCA mark is properly applied and that the technical documentation is in order and can
be made available to the UK enforcement authorities.
How will our EU Representative Service help you?
Authorised Representative Service will act as your responsible economic operator/your UK responsible person and carry out the following obligations for
you:
❖We will verify that your Declaration of Conformity (or Incorporation, Performance,
etc.) and technical documentation has been drawn up correctly.
❖We will keep these documents at the disposal of market surveillance authorities for
the period required by that legislation and ensure that the technical documentation
can be made available to those authorities upon request.
❖Upon request from a market surveillance authority, we will ensure that the technical
documentation can be made available to them in order to demonstrate the conformity of the product.
❖If we have reason to believe that a product presents a risk, we will highlight this
information to the necessary parties.
❖If a risk is identified, we will liaise with you and support you in taking immediate, necessary, corrective action to remedy any noncompliance causing the risk.
❖As your Authorised Representative, we will provide you with our name and contact details, for you to place on the product, it’s packaging or accompanying
documentation.
Clinical/Medical Writing
Clinical Evaluation Report (CER) is one of the key changes after the
implementation of MDR where medical device manufacturers struggle to
cope with. We offer complete solution related to Clinical according to EU
MDR
• Clinical Strategy
• Preparation of Clinical Evaluation Plan
• Literature search, appraisal and literature analysis
• Compilation of Clinical Evaluation Report (CER)
• Communication with the notified body and query management
• Post Market Clinical Follow-up report
• Training for CER and PMCF
Regulatory Affairs
Training
- Clinical Evaluation Report writing with literature
search, appraisal and compilation - QMS: ISO 13485, ISO 9001, ICH Q10
- Post Market Clinical Follow-up report
- EU MDR/IVDR/MEDDEV
- Good Manufacturing Practice (GMP).
- Regulatory Requirements for global markets.
- Design Control.
- FDA registration process.
- Biocompatibility of medical devices to manage
biological risk: ISO 10993 - Tailored training to suit your organisation
Auditing
❑ QMS Audits: We conduct internal and external audits of our clients’
QMS to ensure compliance with regulatory requirements and identify
areas for improvement.
❑ Supplier audit: We provide guidance on managing suppliers and
ensuring that their quality systems meet the requirements of the
medical device industry.
❑ Internal Audit: …..
- QMS: ISO 13485, ISO 9001, ICH Q10
- EU MDR/IVDR/MEDDEV
- Pharmacovigilance: EU Volume 9b, PV/Adverse Events, Directive
2001/82/EC - MDSAP (Medical Device Single Audit Program)
- Supplier quality system
- GxP audits for the pharmaceutical, medical device and related
industries 21 CFR part 210/211, 820, part 58 (GLP), 21 CFR part
600 - Clinical Audit: Clinical Evaluation Report, Post Market Clinical
Follow-up, Clinical investigation ISO 14155, ICH GCP, ICH E6 / - Sterilization of health care products ISO 11135, ISO 11137
- Biocompatibility of medical devices to manage biological risk: ISO
10993 - Medical Device Software: ISO 62304, IEC 82304
- Medical device Risk Management: ISO 14971,
- Medical devices utilizing animal tissues and their derivatives: ISO
22442
MDR/IVDR Transition
We offer a comprehensive range of services to support the compliance of
medical device companies with the EU Medical Device Regulation (MDR)
and EU In Vitro Diagnostic Medical Device Regulation (IVDR). Our services
include:
- IVDR/MDR Gap Assessment: We conduct a thorough assessment of
your current regulatory compliance and identify the gap between your
current compliance status and the requirements of the IVDR / MDR. - Technical File Remediation: We assist in the development and updating
of your Technical Files to meet the requirements of the IVDR / MDR and
provide guidance on how to maintain them. - Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
Writing: We help in the preparation and review of CERs and PERs, which is
a key requirement of MDR and IVDR. - Scientific Validity Report writing: we help in the preparation and review
of SVR. - Notified Body Assessment: We provide guidance and support in the
selection of a Notified Body for IVD and assist in the preparation and
submission of the application for certification. - Training: We offer training on the IVDR / MDR and its requirements,
including the transition process and the new classification system, to
ensure that your team is prepared for the changes ahead.
Our team of experts has extensive experience in navigating the regulatory
requirements for IVD / MD and can provide the guidance and support
needed to ensure a successful transition to the IVDR / MDR. We work
closely with our clients to understand their unique needs and develop
customized solutions to support their success.
Templates and Tools
- Technical File
- General safety and performance requirements
- Performance Evaluation Plan & Report
- Analytical Performance Plan & Report
- Clinical Performance Plan & Report
- Scientific Validity Reports
a. Literature search and selection protocol
b. Literature selection tables
c. Literature search and selection report
d. Scientific Validity Report - Post-Market Surveillance (PMS)
a. Post-market Surveillance Plan
b. Post-market Surveillance Report
c. Periodic Safety Update Report
d. Post-market Performance Follow-up Plan
e. Post-market Performance Follow-up Evaluation Report
f. Summary of Safety and Performance - Risk Management System
a. Risk Management Plan
b. Risk Management Report
c. Risk Analysis FMEA Tables (incl. examples)
d. Risk Assessment Record
e. Roadmap to Risk Assessment
Quality Management
We offer a range of services to support the development and implementation of a Quality Management System (QMS) for medical device companies. Our services
include:
- QMS Development: We assist our clients in developing a QMS that meets the requirements of ISO 13485, MDR, IVDR and 21 CFR 820, as well as any other relevant international standards.
- QMS Audits: We conduct internal and external audits of our clients’ QMS to ensure compliance with regulatory requirements and identify areas for
improvement. - Supplier Quality Management: We provide guidance on managing suppliers and ensuring that their quality systems meet the requirements of the medical device industry.
- CAPA: We help our clients develop and implement a Corrective and Preventive Action (CAPA) system to address non-conformances and prevent recurrence.
- Risk Management: We assist our clients in identifying, evaluating, and
controlling the risks associated with their devices throughout the product
lifecycle. - Training: We offer training on various aspects of QMS, including ISO 13485, MDR, IVDR, 21 CFR 820, and other relevant international standards.
UK/EU Authorised Representatives/ Person Responsible for Regulatory Compliance (PRRC)
As your EU Authorised Representatives, our goal is to help you get your products ready to be sold. Our authorised representatives ensure that all of
your important technical documentation and your declaration of conformity is drawn up in the correct way, we also keep your documents at the
disposal of the market surveillance authorities for the required period. If your product proposes a risk, we can guide you in how to take the
necessary corrective action to rectify any issues, our representative services are in place to ensure full compliance.
As your UK authorised representatives, we help you get your products out in to the world by assuring you fully comply with all regulations and
directives in the UK. We make sure all of your UK Declaration of Conformity and technical documentation has been drawn up correctly and keep
them at the disposal of market surveillance authorities for the required period. If we identify any risk with your products, we can support you
through remedying any non-compliance.
Person Responsible for Regulatory Compliance (PRRC) is a requirement for medical device and IVD manufacturers and Authorised Representative:
article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) state that each manufacturer and authorised representative (if applicable)
must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.
Why do you need a EU Authorised Representative?
How will our EU Representative Service help you?
Authorised Representative Service will act as your responsible economic operator/your UK responsible person and carry out the following obligations for
you:
❖We will verify that your Declaration of Conformity (or Incorporation, Performance,
etc.) and technical documentation has been drawn up correctly.
❖We will keep these documents at the disposal of market surveillance authorities for
the period required by that legislation and ensure that the technical documentation
can be made available to those authorities upon request.
❖Upon request from a market surveillance authority, we will ensure that the technical
documentation can be made available to them in order to demonstrate the conformity of the product.
❖If we have reason to believe that a product presents a risk, we will highlight this
information to the necessary parties.
❖If a risk is identified, we will liaise with you and support you in taking immediate, necessary, corrective action to remedy any noncompliance causing the risk.
❖As your Authorised Representative, we will provide you with our name and contact details, for you to place on the product, it’s packaging or accompanying
documentation.