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Quality Management System - ISO 9001 & 13485
Unikal Consultants undertakes complete project leading to certification in ISO 9001, ISO 13485 and related QMS.
Our services include guidance in relevant QMS documentation, training & implementation.
This is carried by Strategic Review and Planning, Pre Assessment Certification Review Audit, System Design and Documentation, support in Certification Body Selection. The company conducts training sessions for various aspects relating to Quality Management like Assessor training, Kaizen, 5S etc. Company audits as their Internal QMS auditors.
Support for MDSAP preparation leading to certification is given in collaboration with experience team of consultants.
CE Certification
Unikal Consultants specializes in consulting for CE Certification of Medical Devices.
For companies requiring a CE mark for their product for exporting to the European Community, the Company assists with interpreting the standard and outlining the requirements for obtaining the CE mark.
The company gives complete guidance and advice from site / plant compliance to documentation e.g. Device Master File preparation, implementation of system as per MDR 2017/765 and training to staff of Medical Device manufacturers to obtain CE marking for their medical devices. The company's completed and ongoing assignments for CE certification include Devices falling in class I (all), IIa, IIb and class III including Drug Device Combination products.
Device Master File Preparation
As part of the CE requirements a Device Technical (Master) File has to be prepared to outline the safety requirements of the product and risk management. Unikal will assist you in the preparation of the Technical File to meet the review of the third party certification.
Design file, product utility file & The Risk Management file is integral part of the Medical Device DMF.
Clinical evaluation and clinical trial protocols to complete execution is undertaken with support of our collaborating consulting team.
Guidance on tests required and selection of test laboratories for pre-clinical studies & trials with subject experts is available.
Selection of European Authorized Representative Services
The legislation of the European Union, United Kingdom require manufacturers to appoint a professional representative to market medical devices and IVD medical devices on their territory.
Unikal Consultants represent EARP service providers based in EU countries. They offer representation and support to access the EU, UK markets
For medical devices and in-vitro diagnostic devices, the EU Regulations (MDR and IVDR) foresee that non-EU manufacturers must appoint an EU-based authorised representative that plays a pivotal role in compliance of their devices and acts as a contact point in the EU.
We are part of Obelis International Offices (OIO) network -
refer Obelis.net
Selection of Certifying / Notified Body
The CE Mark Certification requires a third party review of the facility & Technical file to assure conformity to the standard. Unikal will assist you in the selection of this Notified Body, prepare the application and will be during the certification audit.
US FDA Representative services
A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.
US FDA Agent Representation for Medical Device and IVD Companies
Appoint Unikal or associates as your registered US FDA Agent representation and learn about our responsibilities as the liaison between your medical device or IVD company and the FDA.
Few answers:
Why is the representation requirement in the United States?
What are the responsibilities of a US Agent?
Can we appoint a distributor as our US Agent?
The United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a presence in the United States to appoint a registered US FDA Agent. The US FDA Agent must be a resident of the United States or maintain a physical place of business in the US. Your US Agent serves as a liaison between your company and the FDA.
Q1. What are the responsibilities of a US FDA Agent?
Appointing a US Agent is more than a regulatory obligation. The responsibilities of the US Agent include:
Assisting the FDA in communications with your company;
Responding to questions concerning your imported products sold in the US;
Assisting the FDA in scheduling inspections of your facilities.
The FDA may also provide information or documents to your US agent, which is considered equivalent to providing them to your company. For this reason, it is important to appoint a professional, dependable regulatory firm to represent your interests.
Please note that we do NOT provide US Agent representation for FOOD or PHARMACEUTICAL companies.
Common questions regarding US FDA agent representation
Q2. What is an Official Correspondent?
The Official Correspondent is the person identified in the establishment registration that the FDA will try to contact first if an issue arises. However, unlike the US Agent, the Official Correspondent does not need to be located in the US and may be a representative of your company.
Audit, Documentation and GMP
Unikal advises Pharmaceutical Companies for c-GMP, WHO-GMP, Documentation as per US-FDA and DMF preparation and Documentation and Quality Assurance systems.
Technology & Know-How
Unikal undertakes Medical Device Manufacturing Projects. These include process setup at pilot scale and up-gradation to Plant scale, Production, establishing QA systems and analytical methods/process development & validation.
The Company specializes in Consulting for Technologies in:
Planning, Implementation and commissioning of Medical Device Manufacturing Projects
Product Developmental work & Technology Transfer
Development & Validation of Processes / Analytical Methods & Quality control techniques
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+91-9824017850