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Services 

This is a Non- complete list, contact us for more information

Hoff

Regulatory 

There are many regulatory requirements that effects companies, Acronyms like IVDR, MDR, FDA, CFR, MD, FCC. EMC, USdot, NRC, WEEE, Rohs and REACH. All represent possible pitfalls to ensure predictable market access.

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Quality and Management Systems

In most regulations for IVD and Medical devices it is a must to have a management system! There are also an increasing need for  systems to manage CSR and IT security aspects on your business.

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Trade Compliance


Trade compliance &
Export control applies to all companies. These regulations often falls under global agreements to prevent terrorism but also limit access of technology for some countries.

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Training and Education

To keep or build required competence  training is a must!
We do training and education activities in most areas. We are also active in holding seminars and speeches in conferences to keep you updated on the latest!

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Regulatory Services

Authorised Representative

We are AR within EU! just contact us to get more information about prices and additional services we can provide you with!

PRRC

We are Person Responsible for Regulatory Compliance for many companies in northern Europe. Contact us for mer information what we can help you with!

Start Up Package

We have developed a way of working that help startups or smaller companies to get to the EU market in a easy, compliant and predictable way!

Regulatory strategy

Do you need a global or local strategy for how to get your products to the market!

Classification

Classification of the product defines what rules that applies to your product!

Gap analyse

Do you have the documentation needed för CE marking or 510(k) submission

Management systems

Training

 
  • We can train your organization in areas like product standards, QSR, MDR and  IVDR 


Labelling & Promotion

  • What applies for your products. Avoid warning letter or sales stop building robust system

Authority handling

  • Got a letter from FDA or LV, better contact us to get advice on how to handle this!

General

 
  • Advisory and guidance in projects or permanently, interim handling and internal audits are other common services

Internal Audit

We can help you to perform internal audits, set up the system or give advice on what to do!

QMS Development

Do you need to implement or develop mangament systems in ISO 27001, ISO 14001, ISO 3485 and ISO 9001.

Inspection Support

Have you got a letter from FDA or competent authority about inspection or need help in Notified Body audits! contact us!

Moc Audit

 
  • Do you need to prepare for FDA, Notified body or Competent Authority inspections? or just check compliance status

  • Then we are the right partner!


Quality systems

  • We can help you with all aspects of QSR, ISO 9001, ISO 13485 and ISO 14001. We help with parts of the system or support you with complete projects

Regulatory 

  • You might need to ensure that your system meets the regulatory needs for a quality system i.e. adding regulatory specific parts

Strategy

 

  • We can help with all aspects in submission and quality strategies to ensure sustainable market access for your products
  • Dont get behind your competition due to poor planning. Start now!

Trade Compliance

Export Control System

Not having an export control system, to classify products, check customers, and sub suppliers, involved banks etc. Then it is time ta contact us now!

Product Classification

Help in establishing ECCN codes and other important product related classifications. Do you have US content or not?

Export Licenses

We can support in obtaining US (BIS, OFAC), EU or national licenses to export to e.g. embargo or restricted countries. The needs are based on product classification and countries you sell to

Training and Education

Selected areas we provide training in

Regulatory Affairs

Training and educational activities.
Contact us for more details.

510(k)

In this one day coarse we go through how to write and submit a 510(k).  The best way is to  include the contributors typical from R&D to get their understanding.

PRRC

This coarse we have in cooperation with Swedish Medtech organisation. We explore and learn what the PRRC role is about and what to look out for!

CE marking

CE marking of software products. In this one day coarse we go through the whole process from A to Z in what and how the documentation should look like.

Market access

How to get to the market with your product! In this half day course we explore how you should approach this, and what is needed to build a sustainable organisation for this.

Managment systems

Contact us for more details.

1

ISO 13485

How to meet the requirements in the quality mangament standard for Medical devices and IVDs. We also discuss compliance with MDR/IVDR/FDA-
One or two days coarse.

2

How to handle a FDA, MDSAP or authority inspection

Leran how to prepare your organisation before, during and after the audit. Doing this right is very important for getting the right result for you!  This is a half day coarse, preferable including all key members of your team that will face the inspectors.

3

QSR - FDA

In this one day coarse we go through what FDA expects from you in terms of meeting their quality system regulation.

Other areas

Contact us for more details.

Export control

What are the requirements, what do I need to have in place, how to... In this half day coarse you learn the basics in this regulation that every company needs to know

GDPR

How to setup a compliance program to meet this regulation. In this halfday coarse we will drill down in all aspects of GDPR compliance.

Market access Startup

In this one day coarse we go through everything a startup company needs to know and work with. We will use examples to visualize  the challenges and what you can do to be able to be on top of them!

Compliance Organization

What to think about when you organize your compliance work. How to fit MDR, CSR, PRRC, GDPR, CSO and all other activites you need to manage.

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Address

Högåsvägen 125
SE- 741 41 Knivsta
Sweden

Contacts

Email: info@lowendahl.eu
Phone: +46 (0) 722 31 33 55

Links

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